Study of the effect of early bolus dose of tirofiban in emergency department on early TIMI flow 3 of the patients with myocardial infarction undergoing primary PCI
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Protocol summary
The aim of this study is to consider the effect of early bolus adminstration of tirofiban in emergency department on early TIMI flow of the patients with myocardial infarction undergoing primary PCI. Inclusion criteria are the patients admitted in Tehran heart center emergency department with acute ST elevation myocardial infarction or new left bundle branch block within 12 hours of onset of symptoms and are candidate for primary PCI within 90 minutes of presentations to the emergency department. Exclusion criteria are contraindications for fibrinolysis, severe hepatic or renal failure, age more than 75 years old and fibrinolytic therapy within 24 hours from randomization. The sample size is 70 for each group. The patients are randomized into the following 2 groups. Intervention group are prescribed 25 mcg/kg of bolus intravenous tirofiban in 1-3 minutes as soon as possible in the emergency department. The control group will not receive tirofiban. Other drugs are prescribed according to decision of clinician in both groups. The primary endpoint is TIMI flow 3 in both groups.
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The aim of this study is to consider the effect of early bolus adminstration of tirofiban in emergency department on early TIMI flow of the patients with myocardial infarction undergoing primary PCI. Inclusion criteria are the patients admitted in Tehran heart center emergency department with acute ST elevation myocardial infarction or new left bundle branch block within 12 hours of onset of symptoms and are candidate for primary PCI within 90 minutes of presentations to the emergency department. Exclusion criteria are contraindications for fibrinolysis, severe hepatic or renal failure, age more than 75 years old and fibrinolytic therapy within 24 hours from randomization. The sample size is 70 for each group. The patients are randomized into the following 2 groups. Intervention group are prescribed 25 mcg/kg of bolus intravenous tirofiban in 1-3 minutes as soon as possible in the emergency department. The control group will not receive tirofiban. Other drugs are prescribed according to decision of clinician in both groups. The primary endpoint is TIMI flow 3 in both groups.
هدف از انجام این مطالعه بررسی اثر تجویز دوز زودرس بولوس تیروفیبان در اورژانس بر TIMI Flow اولیه در بیماران مبتلا به انفارکتوس حاد میوکارد که قرار است مورد Primary PCI قرار گیرند. معیار ورود به طرح عبارت است از: تشخیص انفارکتوس حاد قلبی ازنوع STEMI و یا بلوک شاخه چپ قلب جدیدکه در عرض 12 ساعت از شروع علائم به اورژانس مراجعه کرده باشند و در عرض 90 دقیقه از ورودشان به اورژانس امکان PCI اولیه وجود داشته باشد. معیارهای خروج از طرح شامل کنتراندیکاسیونهای تجویز فیبرینولیز و نارسایی شدید کبد و کلیه و سن بالای 75 سال و دریافت هر نوع فیبرینولیز در عرض 24 ساعت گذشته است. حجم نمونه محاسبه شده برای این مطالعه 70 نفر برای هرگروه و جمعاً 140 نفر است. گروه مداخله بصورت تصادفی تعیین شده و در اورژانس و به محض امکان 25 میکروگرم بازای هر کیلوگرم وزن بدن تیروفیبان در عرض 1-3 دقیقه دریافت می کند. گروه کنترل در اورژانس تیروفیبان نمی گیرتد. سایر داروها در دو گروه بر اساس صلاحدید پزشک تجویز می شوند. پیامد اولیه 3 TIMI flow بیماران دو گروه است.
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هدف از انجام این مطالعه بررسی اثر تجویز دوز زودرس بولوس تیروفیبان در اورژانس بر TIMI Flow اولیه در بیماران مبتلا به انفارکتوس حاد میوکارد که قرار است مورد Primary PCI قرار گیرند. معیار ورود به طرح عبارت است از: تشخیص انفارکتوس حاد قلبی ازنوع STEMI و یا بلوک شاخه چپ قلب جدیدکه در عرض 12 ساعت از شروع علائم به اورژانس مراجعه کرده باشند و در عرض 90 دقیقه از ورودشان به اورژانس امکان PCI اولیه وجود داشته باشد. معیارهای خروج از طرح شامل کنتراندیکاسیونهای تجویز فیبرینولیز و نارسایی شدید کبد و کلیه و سن بالای 75 سال و دریافت هر نوع فیبرینولیز در عرض 24 ساعت گذشته است. حجم نمونه محاسبه شده برای این مطالعه 70 نفر برای هرگروه و جمعاً 140 نفر است. گروه مداخله بصورت تصادفی تعیین شده و در اورژانس و به محض امکان 25 میکروگرم بازای هر کیلوگرم وزن بدن تیروفیبان در عرض 1-3 دقیقه دریافت می کند. گروه کنترل در اورژانس تیروفیبان نمی گیرتد. سایر داروها در دو گروه بر اساس صلاحدید پزشک تجویز می شوند. پیامد اولیه 3 TIMI flow بیماران دو گروه است.
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ْThe aim of this study is to consider the effect of early bolus adminstration of tirofiban in emergency department on early TIMI flow of the patients with myocardial infarction undergoing primary PCI.
ْThe aim of this study is to consider the effect of early bolus adminstration of tirofiban in emergency department on early TIMI flow of the patients with myocardial infarction undergoing primary PCI.
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هدف از انجام این مطالعه بررسی اثر تجویز دوز زودرس بولوس تیروفیبان در اورژانس بر TIMI Flow اولیه در بیماران مبتلا به انفارکتوس حاد میوکارد که قرار است مورد Primary PCI قرار گیرند.
هدف از انجام این مطالعه بررسی اثر تجویز دوز زودرس بولوس تیروفیبان در اورژانس بر TIMI Flow اولیه در بیماران مبتلا به انفارکتوس حاد میوکارد که قرار است مورد Primary PCI قرار گیرند.
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Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
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کارآزمایی بالینی دارای گروه کنترل، مبتنی بر جامعه و عمل گرا، با گروه های موازی ، یک سو سویه کور برای مراقبت بعد از اقدام و ارزیابی نتایج، تصادفی شده
کارآزمایی بالینی دارای گروه کنترل، مبتنی بر جامعه و عمل گرا، با گروه های موازی ، یک سو سویه کور برای مراقبت بعد از اقدام و ارزیابی نتایج، تصادفی شده
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Tehran heart center
Tehran heart center
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مرکز قلب تهران
مرکز قلب تهران
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Inclusion criteria are the patients admitted in Tehran heart center emergency department with acute ST elevation myocardial infarction or new left bundle branch block within 12 hours of onset of symptoms and are candidate for primary PCI within 90 minutes of presentations to the emergency department. Exclusion criteria are contraindications for fibrinolysis, severe hepatic or renal failure, age more than 75 years old and fibrinolytic therapy within 24 hours from randomization. The sample size is 70 for each group.
Inclusion criteria are the patients admitted in Tehran heart center emergency department with acute ST elevation myocardial infarction or new left bundle branch block within 12 hours of onset of symptoms and are candidate for primary PCI within 90 minutes of presentations to the emergency department. Exclusion criteria are contraindications for fibrinolysis, severe hepatic or renal failure, age more than 75 years old and fibrinolytic therapy within 24 hours from randomization. The sample size is 70 for each group.
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معیار ورود به طرح عبارت است از: تشخیص انفارکتوس حاد قلبی ازنوع STEMI و یا بلوک شاخه چپ قلب جدیدکه در عرض 12 ساعت از شروع علائم به اورژانس مراجعه کرده باشند و در عرض 90 دقیقه از ورودشان به اورژانس امکان PCI اولیه وجود داشته باشد. معیارهای خروج از طرح شامل کنتراندیکاسیونهای تجویز فیبرینولیز و نارسایی شدید کبد و کلیه و سن بالای 75 سال و دریافت هر نوع فیبرینولیز در عرض 24 ساعت گذشته است.
معیار ورود به طرح عبارت است از: تشخیص انفارکتوس حاد قلبی ازنوع STEMI و یا بلوک شاخه چپ قلب جدیدکه در عرض 12 ساعت از شروع علائم به اورژانس مراجعه کرده باشند و در عرض 90 دقیقه از ورودشان به اورژانس امکان PCI اولیه وجود داشته باشد. معیارهای خروج از طرح شامل کنتراندیکاسیونهای تجویز فیبرینولیز و نارسایی شدید کبد و کلیه و سن بالای 75 سال و دریافت هر نوع فیبرینولیز در عرض 24 ساعت گذشته است.
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The sample size is 70 for each group. The patients are randomized into the following 2 groups. Intervention group are prescribed 25 mcg/kg of bolus intravenous tirofiban in 1-3 minutes as soon as possible in the emergency department. The control group will not receive tirofiban.
The sample size is 70 for each group. The patients are randomized into the following 2 groups. Intervention group are prescribed 25 mcg/kg of bolus intravenous tirofiban in 1-3 minutes as soon as possible in the emergency department. The control group will not receive tirofiban.
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حجم نمونه محاسبه شده برای این مطالعه 70 نفر برای هرگروه و جمعاً 140 نفر است. گروه مداخله بصورت تصادفی تعیین شده و در اورژانس و به محض امکان 25 میکروگرم بازای هر کیلوگرم وزن بدن تیروفیبان در عرض 1-3 دقیقه دریافت می کند. گروه کنترل در اورژانس تیروفیبان نمی گیرند.
حجم نمونه محاسبه شده برای این مطالعه 70 نفر برای هرگروه و جمعاً 140 نفر است. گروه مداخله بصورت تصادفی تعیین شده و در اورژانس و به محض امکان 25 میکروگرم بازای هر کیلوگرم وزن بدن تیروفیبان در عرض 1-3 دقیقه دریافت می کند. گروه کنترل در اورژانس تیروفیبان نمی گیرند.
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ُEarly TIMI flow of the patients with myocardial infarction undergoing primary PCI.
ُEarly TIMI flow of the patients with myocardial infarction undergoing primary PCI.
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TIMI Flow اولیه در بیماران مبتلا به انفارکتوس حاد میوکارد که قرار است مورد Primary PCI قرار گیرند.
TIMI Flow اولیه در بیماران مبتلا به انفارکتوس حاد میوکارد که قرار است مورد Primary PCI قرار گیرند.
General information
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140
140
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2011-03-06, 1389/12/15
2011-03-06 00:00:00
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2012-03-19, 1390/12/29
2012-03-19 00:00:00
Inclusion criteria: Acute myocardial infarction patient with ST segment elevation or new left bundle branch block in 12 hours of onset of symptoms and are candidate for primary PCI within 90 minutes of presentations to the emergency department
Inclusion criteria: Acute myocardial infarction patient with ST segment elevation or new left bundle branch block in 12 hours of onset of symptoms and are candidate for primary PCI within 90 minutes of presentations to the emergency department
معیارهای ورود: ابتلا به انفارکتوس حاد میوکارد با بالا رفتن قطعه ST یا بلوک شاخه چپ جدید که در 12 ساعت اول از شروع علائم مراجعه کرده اند و امکانات مرکز قادر به انجام Primary PCI در عرض 90 دقیقه از مراجعه به اورژانس باشد
معیارهای ورود: ابتلا به انفارکتوس حاد میوکارد با بالا رفتن قطعه ST یا بلوک شاخه چپ جدید که در 12 ساعت اول از شروع علائم مراجعه کرده اند و امکانات مرکز قادر به انجام Primary PCI در عرض 90 دقیقه از مراجعه به اورژانس باشد
Exclusion criteria: Stroke or TIA within the past 30 days or any history of hemorrhagic stroke, well known intra cranial disease (neoplasm or aneurysm), any active bleeding or bleeding history in past 30 days, uncontrolled HTN at registry time (SBP>180, DBP>110), Major operation or trauma in recent 6 weeks, platlete count less than 100000 or bleeding conditions, Coagulation disorders (INR>1.5), Severe hepatic failure, Administration of any fibrinolytic treatment 24 hours from randomization, Renal failure (Cr>205mg/dl or GFR <30), age more than 75 years old
Exclusion criteria: Stroke or TIA within the past 30 days or any history of hemorrhagic stroke, well known intra cranial disease (neoplasm or aneurysm), any active bleeding or bleeding history in past 30 days, uncontrolled HTN at registry time (SBP>180, DBP>110), Major operation or trauma in recent 6 weeks, platlete count less than 100000 or bleeding conditions, Coagulation disorders (INR>1.5), Severe hepatic failure, Administration of any fibrinolytic treatment 24 hours from randomization, Renal failure (Cr>205mg/dl or GFR <30), age more than 75 years old
معیارهای خروج: سکته مغزی یا TIA در 30 روز گذشته یا سکته مغزی هموراژیک در هر زمان، بیماری داخل مغزی شناخته شده (انوریسم یا نئوپلاسم)، خونریزی فعال یا سابقه آن در 30 روز گذشته، هیپرتانسیون کنترل نشده در زمان ورود به مطالعه، SBP>180 mmHg, DBP>110 mmHg، جراحی عمده یا تروما در 6 هفته اخیر، پلاکت کمتر از100000 یا شرایط خونریزی دهنده شناخته شده، اختلال انعقادی با INR بیش از 5/1، نارسایی کبدی شدید، درمان با فیبرینولیتیک در عرض 24 ساعت از تصادفی سازی، نارسایی کلیوی، ( GFR <30 یا Cr>2.5 mg/dl)، سن بالای 75 سال
معیارهای خروج: سکته مغزی یا TIA در 30 روز گذشته یا سکته مغزی هموراژیک در هر زمان، بیماری داخل مغزی شناخته شده (انوریسم یا نئوپلاسم)، خونریزی فعال یا سابقه آن در 30 روز گذشته، هیپرتانسیون کنترل نشده در زمان ورود به مطالعه، SBP>180 mmHg, DBP>110 mmHg، جراحی عمده یا تروما در 6 هفته اخیر، پلاکت کمتر از100000 یا شرایط خونریزی دهنده شناخته شده، اختلال انعقادی با INR بیش از 5/1، نارسایی کبدی شدید، درمان با فیبرینولیتیک در عرض 24 ساعت از تصادفی سازی، نارسایی کلیوی، ( GFR <30 یا Cr>2.5 mg/dl)، سن بالای 75 سال
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Block randomization
Block randomization
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تصادفی سازی بلوکی
تصادفی سازی بلوکی
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Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Are blinded by coding to the subjects
Participant Outcome assessor Data analyser Data and Safety Monitoring Board Are blinded by coding to the subjects
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مطالعه شوندگان، بررسی کنندگان نتیجه، انالیز کننده داده ها، و گروه پایش اطلاعات با کد دادن اطلاعات تسبت به مطالعه کور نگه داشته شده اند.
مطالعه شوندگان، بررسی کنندگان نتیجه، انالیز کننده داده ها، و گروه پایش اطلاعات با کد دادن اطلاعات تسبت به مطالعه کور نگه داشته شده اند.
Primary outcomes
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TIMI 3 flow score prevalency in coronary angiography
Prevalence of TIMI 3 flow score in coronary angiography
Prevalence of TIMI 3 flow score prevalency in coronary angiography
Recruitment centers
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Name of recruitment center - English: Tehran Heart Center
Name of recruitment center - Persian: مرکز قلب تهران
Full name of responsible person - English: Dr Mehdi Moosavi
Full name of responsible person - Persian: دکتر مهدی موسوی
Street address - English: Jalal Al Ahmad & North Kargar Cross
Street address - Persian: تقاطع خیابان کارگر شمالی و بزرگراه جلال آل احمد
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Tehran Heart Center
Name of recruitment center - Persian: مرکز قلب تهران
Full name of responsible person - English: Dr Mehdi Moosavi
Full name of responsible person - Persian: دکتر مهدی موسوی
Street address - English: Jalal Al Ahmad & North Kargar Cross
Street address - Persian: تقاطع خیابان کارگر شمالی و بزرگراه جلال آل احمد
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1411713138
Phone: +98 21 8802 9721
Fax:
Email: mmoosavi@razi.tums.ac.ir
Web page address:
Name of recruitment center - English: Tehran Heart Center Name of recruitment center - Persian: مرکز قلب تهران Full name of responsible person - English: Dr Mehdi Moosavi Full name of responsible person - Persian: دکتر مهدی موسوی Street address - English: Jalal Al Ahmad & North Kargar Cross Street address - Persian: تقاطع خیابان کارگر شمالی و بزرگراه جلال آل احمد City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1411713138 Phone: +98 21 8802 9721 Fax: Email: mmoosavi@razi.tums.ac.ir Web page address:
Sponsors / Funding sources
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contact.organization_id:
Name of organization / entity - English: Tehran Heart Center
Name of organization / entity - Persian: مرکز قلب تهران
Full name of responsible person - English: Dr Seyed Hesammeddin Abbasi
Full name of responsible person - Persian: دکتر سید حسام الدین عباسی
Street address - English: North kargar and Jalal al Ahmad cross
Street address - Persian: تقاطع خیابان کارگر شمالی و بزرگراه جلال آل احمد
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr Seyed Hesammeddin Abbasi
Full name of responsible person - Persian: دکتر سید حسام الدین عباسی
Street address - English: North kargar and Jalal al Ahmad cross
Street address - Persian: تقاطع خیابان کارگر شمالی و بزرگراه جلال آل احمد
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1411713138
Phone:
Fax:
Email: mmoosavi@razi.tums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Tehran Heart Center Name of organization / entity - Persian: مرکز قلب تهران Full name of responsible person - English: Dr Seyed Hesammeddin Abbasi Full name of responsible person - Persian: دکتر سید حسام الدین عباسی Street address - English: North kargar and Jalal al Ahmad cross Street address - Persian: تقاطع خیابان کارگر شمالی و بزرگراه جلال آل احمد City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1411713138 Phone: Fax: Email: mmoosavi@razi.tums.ac.ir Web page address:
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Public
public
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Domestic
domestic
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Academic
academic
Tehran Heart Center
Tehran University of Medical Sciences
Tehran Heart CenterUniversity of Medical Sciences
مرکز قلب تهران
دانشگاه علوم پزشکی تهران
مرکز قلبدانشگاه علوم پزشکی تهران
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: Tehran Heart Center
Name of organization / entity - Persian: مرکز قلب تهران
Full name of responsible person - English: Dr Seyed Hesameddin Abbasi
Full name of responsible person - Persian: دکتر سید حسام الدین عباسی
Position - English: Managing editor of Journal of Tehran Heart Center
Position - Persian: سرپرست (مدیر ویرایش) مجله مرکز قلب تهران
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Jalal Al Ahmad & North Kargar cross
Street address - Persian: تقاطع خیابان کارگر شمالی و بزرگراه جلال آل احمد
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1411713138
Phone: +98 21 8802 9702
Mobile: +98 912 157 5226
Fax: +98 21 8802 9256
Email: Abbasi.hesam@gmail.com
Web page address: http://thc.ac.ir
contact.organization_id:
Name of organization / entity - English: Tehran Heart Center
Name of organization / entity - Persian: مرکز قلب تهران
Full name of responsible person - English: Dr Seyed Hesameddin Abbasi
Full name of responsible person - Persian: دکتر سید حسام الدین عباسی
Position - English: Managing editor of Journal of Tehran Heart Center
Position - Persian: سرپرست (مدیر ویرایش) مجله مرکز قلب تهران
Latest degree: phd
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Jalal Al Ahmad & North Kargar cross
Street address - Persian: تقاطع خیابان کارگر شمالی و بزرگراه جلال آل احمد
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1411713138
Phone: +98 21 8802 9702
Mobile: +98 912 157 5226
Fax: +98 21 8802 9256
Email: Abbasi.hesam@gmail.com
Web page address: http://thc.ac.ir
contact.organization_id: Name of organization / entity - English: Tehran Heart Center Name of organization / entity - Persian: مرکز قلب تهران Full name of responsible person - English: Dr Seyed Hesameddin Abbasi Full name of responsible person - Persian: دکتر سید حسام الدین عباسی Position - English: Managing editor of Journal of Tehran Heart Center Position - Persian: سرپرست (مدیر ویرایش) مجله مرکز قلب تهران Latest degree: phd Area of specialty/work: 0 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Jalal Al Ahmad & North Kargar cross Street address - Persian: تقاطع خیابان کارگر شمالی و بزرگراه جلال آل احمد City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1411713138 Phone: +98 21 8802 9702 Mobile: +98 912 157 5226 Fax: +98 21 8802 9256 Email: Abbasi.hesam@gmail.com Web page address: http://thc.ac.ir
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: Tehran Heart Center
Name of organization / entity - Persian: مرکز قلب تهران
Full name of responsible person - English: Dr Mehdi Mousavi
Full name of responsible person - Persian: دکترمهدی موسوی
Position - English: Cardiologist, Fellow of interventional cardiology
Position - Persian: متخصص قلب فلو اینترونشنال کاردیولوؤی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Jalal Al Ahmad & North Kargar cross
Street address - Persian: خ جلال ال احمد مرکز قلب تهران
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1411713138
Phone: +98 21 8802 9600
Mobile: +98 912 305 3284
Fax: +98 21 8802 9256
Email: mmoosavi@razi.tums.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Tehran Heart Center
Name of organization / entity - Persian: مرکز قلب تهران
Full name of responsible person - English: Dr Mehdi Mousavi
Full name of responsible person - Persian: دکترمهدی موسوی
Position - English: Cardiologist, Fellow of interventional cardiology
Position - Persian: متخصص قلب فلو اینترونشنال کاردیولوؤی
Latest degree: specialist
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Jalal Al Ahmad & North Kargar cross
Street address - Persian: خ جلال ال احمد مرکز قلب تهران
City - English: Tehran
City - Persian: تهران
Province: Alborz
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1411713138
Phone: +98 21 8802 9600
Mobile: +98 912 305 3284
Fax: +98 21 8802 9256
Email: mmoosavi@razi.tums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Tehran Heart Center Name of organization / entity - Persian: مرکز قلب تهران Full name of responsible person - English: Dr Mehdi Mousavi Full name of responsible person - Persian: دکترمهدی موسوی Position - English: Cardiologist, Fellow of interventional cardiology Position - Persian: متخصص قلب فلو اینترونشنال کاردیولوؤی Latest degree: specialist Area of specialty/work: 0 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Jalal Al Ahmad & North Kargar cross Street address - Persian: خ جلال ال احمد مرکز قلب تهران City - English: Tehran City - Persian: تهران Province: Alborz Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1411713138 Phone: +98 21 8802 9600 Mobile: +98 912 305 3284 Fax: +98 21 8802 9256 Email: mmoosavi@razi.tums.ac.ir Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Tehran Heart Center
Name of organization / entity - Persian: مرکز قلب تهران
Full name of responsible person - English: Dr Neda Ghaffari-marandi
Full name of responsible person - Persian: دکتر ندا غفاری مرندی
Position - English: Research associate
Position - Persian: پژوهشگر واحد تحقیقات مرکز قلب
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Jalal Al Ahmad & North Kargar cross
Street address - Persian: تقاطع خیابان کارگر شمالی و مرکز قلب تهران
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1411713138
Phone: +98 21 8802 9600
Mobile: +98 912 276 4707
Fax: +98 21 8802 9256
Email: nghaffari303@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr Mehdi Mousavi
Full name of responsible person - Persian: دکتر مهدی موسوی
Position - English: Fellowsip
Position - Persian: فلوشیپ
Latest degree: specialist
Area of specialty/work: 71
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Jalal Al Ahmad & North Kargar cross
Street address - Persian: تقاطع خیابان کارگر شمالی و مرکز قلب تهران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1411713138
Phone: +98 21 8802 9600
Mobile: +98 912 305 3284
Fax: +98 21 8802 9256
Email: mmoosavi@razi.tums.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Tehran Heart Center Name of organization / entity - Persian: مرکز قلب تهران Full name of responsible person - English: Dr Neda Ghaffari-marandiMehdi Mousavi Full name of responsible person - Persian: دکتر ندا غفاری مرندیمهدی موسوی Position - English: Research associateFellowsip Position - Persian: پژوهشگر واحد تحقیقات مرکز قلبفلوشیپ Latest degree: specialist Area of specialty/work: 071 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Jalal Al Ahmad & North Kargar cross Street address - Persian: تقاطع خیابان کارگر شمالی و مرکز قلب تهران City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1411713138 Phone: +98 21 8802 9600 Mobile: +98 912 276 4707305 3284 Fax: +98 21 8802 9256 Email: nghaffari303mmoosavi@gmail.comrazi.tums.ac.ir Web page address:
Effect of Early Treatment With Tirofiban on Initial TIMI Grade 3 Flow of Patients With ST Elevation Myocardial Infarction.
Salarifar M, Mousavi M, Yousefpour N, Nematipour E, Kassaian SE, Poorhosseini H, Hajizeinali A, Alidoosti M, Aghajani H, Nozari Y, Amirzadegan A, Bozorgi A, Genab Y.
Abstract
Background: Before primary percutaneous coronary intervention (PCI) in patients with ST elevation myocardial infarction (STEMI), it is not clear whether a routine early administration of glycoprotein IIb/IIIa inhibitors in the emergency ward is beneficial or their administration in selected cases in the catheterization laboratory.
Objectives: The present randomized clinical trial sought to investigate whether an earlier administration of Tirofiban could exert any impact on TIMI grade 3 flows and ST resolution in the electrocardiography of patients with STEMI before primary PCI.
Materials and Methods: Patients with STEMI within twelve hours of symptom commencement were included if primary PCI was planned to be performed within ninety minutes of admission and excluded if they had contraindications for Tirofiban. Seventy patients were randomized to receive 25 μg/kg of bolus Tirofiban early in the emergency ward (the early Tirofiban group) in three minutes and 70 did not receive Tirofiban (the control group). The primary endpoint of the study was a Thrombolysis in Myocardial Infarction (TIMI) grade 3 flows on the initial angiogram. The study is registered as IRCT201105126463N1 in: www.irct.ir.
Results: The study population had a mean age of 57.17 ± 10.09 years and included 79.3 % males. TIMI grade 3 flow was seen in 15 (21.4 %) patients of the Tirofiban group and 7 (10 %) of the control group (P = 0.06, odds ratio = 0.407, and 95 % confidence interval = 0.155-1.072). Complete ST resolution was seen in 30 (42.9 %) patients of the Tirofiban group and 34 (48.6 %) of the control group (P = 0.5).
Conclusion: Although TIMI grade 3 flows trended to be higher in the patients who received early Tirofiban in the emergency ward, the difference did not constitute statistical significance and possible benefits, therefore, require further clarification.
Iran Red Cres Med J. 2014 January; 16(1): e9641.
DOI: 10.5812/ircmj.9641
Effect of Early Treatment With Tirofiban on Initial TIMI Grade 3 Flow of Patients With ST Elevation Myocardial Infarction. Salarifar M, Mousavi M, Yousefpour N, Nematipour E, Kassaian SE, Poorhosseini H, Hajizeinali A, Alidoosti M, Aghajani H, Nozari Y, Amirzadegan A, Bozorgi A, Genab Y. Abstract Background: Before primary percutaneous coronary intervention (PCI) in patients with ST elevation myocardial infarction (STEMI), it is not clear whether a routine early administration of glycoprotein IIb/IIIa inhibitors in the emergency ward is beneficial or their administration in selected cases in the catheterization laboratory. Objectives: The present randomized clinical trial sought to investigate whether an earlier administration of Tirofiban could exert any impact on TIMI grade 3 flows and ST resolution in the electrocardiography of patients with STEMI before primary PCI. Materials and Methods: Patients with STEMI within twelve hours of symptom commencement were included if primary PCI was planned to be performed within ninety minutes of admission and excluded if they had contraindications for Tirofiban. Seventy patients were randomized to receive 25 μg/kg of bolus Tirofiban early in the emergency ward (the early Tirofiban group) in three minutes and 70 did not receive Tirofiban (the control group). The primary endpoint of the study was a Thrombolysis in Myocardial Infarction (TIMI) grade 3 flows on the initial angiogram. The study is registered as IRCT201105126463N1 in: www.irct.ir. Results: The study population had a mean age of 57.17 ± 10.09 years and included 79.3 % males. TIMI grade 3 flow was seen in 15 (21.4 %) patients of the Tirofiban group and 7 (10 %) of the control group (P = 0.06, odds ratio = 0.407, and 95 % confidence interval = 0.155-1.072). Complete ST resolution was seen in 30 (42.9 %) patients of the Tirofiban group and 34 (48.6 %) of the control group (P = 0.5). Conclusion: Although TIMI grade 3 flows trended to be higher in the patients who received early Tirofiban in the emergency ward, the difference did not constitute statistical significance and possible benefits, therefore, require further clarification. Iran Red Cres Med J. 2014 January; 16(1): e9641. DOI: 10.5812/ircmj.9641
Protocol summary
Study aim
ْThe aim of this study is to consider the effect of early bolus adminstration of tirofiban in emergency department on early TIMI flow of the patients with myocardial infarction undergoing primary PCI.
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
Tehran heart center
Participants/Inclusion and exclusion criteria
Inclusion criteria are the patients admitted in Tehran heart center emergency department with acute ST elevation myocardial infarction or new left bundle branch block within 12 hours of onset of symptoms and are candidate for primary PCI within 90 minutes of presentations to the emergency department. Exclusion criteria are contraindications for fibrinolysis, severe hepatic or renal failure, age more than 75 years old and fibrinolytic therapy within 24 hours from randomization. The sample size is 70 for each group.
Intervention groups
The sample size is 70 for each group. The patients are randomized into the following 2 groups. Intervention group are prescribed 25 mcg/kg of bolus intravenous tirofiban in 1-3 minutes as soon as possible in the emergency department. The control group will not receive tirofiban.
Main outcome variables
ُEarly TIMI flow of the patients with myocardial infarction undergoing primary PCI.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT201105126463N1
Registration date:2011-06-06, 1390/03/16
Registration timing:registered_while_recruiting
Last update:2018-04-04, 1397/01/15
Update count:1
Registration date
2011-06-06, 1390/03/16
Registrant information
Name
Mehdi Mousavi
Name of organization / entity
Alborz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3457 0030
Email address
mmoosavi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran Heart Center
Expected recruitment start date
2011-03-06, 1389/12/15
Expected recruitment end date
2012-03-05, 1390/12/15
Actual recruitment start date
2011-03-06, 1389/12/15
Actual recruitment end date
2012-03-19, 1390/12/29
Trial completion date
empty
Scientific title
Study of the effect of early bolus dose of tirofiban in emergency department on early TIMI flow 3 of the patients with myocardial infarction undergoing primary PCI
Public title
Effect of early tirofiban adminstration in emergency department on TIMI flow 3
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Acute myocardial infarction patient with ST segment elevation or new left bundle branch block in 12 hours of onset of symptoms and are candidate for primary PCI within 90 minutes of presentations to the emergency department
Exclusion criteria:
Exclusion criteria: Stroke or TIA within the past 30 days or any history of hemorrhagic stroke, well known intra cranial disease (neoplasm or aneurysm), any active bleeding or bleeding history in past 30 days, uncontrolled HTN at registry time (SBP>180, DBP>110), Major operation or trauma in recent 6 weeks, platlete count less than 100000 or bleeding conditions, Coagulation disorders (INR>1.5), Severe hepatic failure, Administration of any fibrinolytic treatment 24 hours from randomization, Renal failure (Cr>205mg/dl or GFR <30), age more than 75 years old
Age
To 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
140
Actual sample size reached:
140
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Are blinded by coding to the subjects
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran Heart Center Ethic committee
Street address
Jalal Al Ahmad & North Kargar cross
City
Tehran
Province
Tehran
Postal code
1411713138
Approval date
2011-01-03, 1389/10/13
Ethics committee reference number
460
Health conditions studied
1
Description of health condition studied
acute myocardial infarction
ICD-10 code
I21
ICD-10 code description
Acute myocardial infarction
Primary outcomes
1
Description
Prevalence of TIMI 3 flow score in coronary angiography
Timepoint
in cath lab before PCI
Method of measurement
according to angiography report
Secondary outcomes
1
Description
Major Cardiac Event
Timepoint
one year
Method of measurement
clinical follow up
Intervention groups
1
Description
Intervention group are prescribed 25 mcg/kg of bolus intravenous tirofiban in 1-3 minutes as soon as possible in the emergency department.
Category
Treatment - Drugs
2
Description
The control group will not receive tirofiban in emergency department.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Dr Mehdi Moosavi
Street address
Jalal Al Ahmad & North Kargar Cross
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9721
Email
mmoosavi@razi.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Seyed Hesammeddin Abbasi
Street address
North kargar and Jalal al Ahmad cross
City
Tehran
Province
Tehran
Postal code
1411713138
Email
mmoosavi@razi.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran Heart Center
Full name of responsible person
Dr Seyed Hesameddin Abbasi
Position
Managing editor of Journal of Tehran Heart Center
Latest degree
Ph.D.
Other areas of specialty/work
Street address
Jalal Al Ahmad & North Kargar cross
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9702
Fax
+98 21 8802 9256
Email
Abbasi.hesam@gmail.com
Web page address
http://thc.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran Heart Center
Full name of responsible person
Dr Mehdi Mousavi
Position
Cardiologist, Fellow of interventional cardiology
Latest degree
Specialist
Other areas of specialty/work
Street address
Jalal Al Ahmad & North Kargar cross
City
Tehran
Province
Alborz
Postal code
1411713138
Phone
+98 21 8802 9600
Fax
+98 21 8802 9256
Email
mmoosavi@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mehdi Mousavi
Position
Fellowsip
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Jalal Al Ahmad & North Kargar cross
City
Tehran
Province
Tehran
Postal code
1411713138
Phone
+98 21 8802 9600
Fax
+98 21 8802 9256
Email
mmoosavi@razi.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The article
When the data will become available and for how long
Mar 2018
To whom data/document is available
Anyone
Under which criteria data/document could be used
No other documents
From where data/document is obtainable
The corresponding author
What processes are involved for a request to access data/document