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Evaluation of the effect of metformin on cardiac troponin-I in STEMI patients treated with thrombolytic therapy

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History
# Registration date Revision Id
2 2020-12-20, 1399/09/30 167716
1 2020-06-02, 1399/03/13 137068
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  • Protocol summary

    This is a prospective, randomized controlled trial on a total of 100 consented patients older than 18 years with thrombolytic therapy who attended the Shahid Madani clinic of Tabriz University of Medical Science.intervention group will recieve اn addition to routine treatment, 1000 mg of metformin before thrombolytic, then metformin 500 mg twice daily for 3 days.Patients in the control group will receive only routine treatment.The blood level of cTnI will be checkedevery 8 hours for 48_72 hours in two groups with and without metformin.
    This is a prospective, randomized controlled trial on a total of 80 consented patients older than 18 years with thrombolytic therapy who attended the Shahid Madani clinic of Tabriz University of Medical Science.intervention group will recieve اn addition to routine treatment, 1000 mg of metformin before thrombolytic.Patients in the control group will receive only routine treatment.The blood level of cTnI will be checkedevery 8 hours for 48_72 hours in two groups with and without metformin.
    این مطالعه به صورت کارآزمایی بالینی تصادفی بر روی صد نفر از بیماران بالای 18سال که فرم رضایت نامه اخلاقی را تکمیل نموده و برای ترومبولایتیک تراپی به درمانگاه مرکز تحقیقاتی و درمانی شهید مدنی تبریز مراجعه کرده اند، انجام می گیرد.بیماران گروه مداخله علاوه بر درمان روتین ۱۰۰۰ میلی گرم متفورمین قبل ترومبولایتیک سپس روزی دو بار متفورمین ۵۰۰ میلی گرم به مدت ۳ روز دریافت می کنند.بیماران گروه کنترل فقط درمان روتین را دریافت خواهند کرد. ارزیابی آنزیم های قلبی در دوگروه هر 8ساعت به مدت 72_48 ساعت اول خواهد بود.
    این مطالعه به صورت کارآزمایی بالینی تصادفی بر روی 80 نفر از بیماران بالای 18سال که فرم رضایت نامه اخلاقی را تکمیل نموده و برای ترومبولایتیک تراپی به درمانگاه مرکز تحقیقاتی و درمانی شهید مدنی تبریز مراجعه کرده اند، انجام می گیرد.بیماران گروه مداخله علاوه بر درمان روتین ۱۰۰۰ میلی گرم متفورمین قبل ترومبولایتیک دریافت می کنند.بیماران گروه کنترل فقط درمان روتین را دریافت خواهند کرد. ارزیابی آنزیم های قلبی در دوگروه هر 8ساعت به مدت 72_48 ساعت اول خواهد بود.
    intervention group will recieve اn addition to routine treatment, 1000 mg of metformin before thrombolytic, then metformin 500 mg twice daily for 3 days.Patients in the control group will receive only routine treatment.
    intervention group will recieve اn addition to routine treatment, 1000 mg of metformin before thrombolytic.Patients in the control group will receive only routine treatment.
    بیماران گروه مداخله علاوه بر درمان روتین ۱۰۰۰ میلی گرم متفورمین قبل ترومبولایتیک سپس روزی دو بار متفورمین ۵۰۰ میلی گرم به مدت ۳ روز دریافت می کنند.بیماران گروه کنترل فقط درمان روتین را دریافت خواهند کرد.
    بیماران گروه مداخله علاوه بر درمان روتین ۱۰۰۰ میلی گرم متفورمین قبل ترومبولایتیک دریافت می کنند.بیماران گروه کنترل فقط درمان روتین را دریافت خواهند کرد.

  • General information

    100
    80
    empty
    The number of people decreased due to Corona virus.
    empty
    تعداد نفرات به خاطر کرونا کم شد .
    Randomization was done using computer systematic randomization by an independent person
    Randomization was done using computer generated random number (systematic randomization) by online Graphpad software by determining 2 study groups and 40 patients in each group (Control and Intervention) by an independent person.
    تصادفی سازی به صورت تصادفی سازی سیستماتیک به وسیله کامپیوتر توسط شخص مستقل انجام گرفت
    تصادفی سازی به صورت تصادفی سازی سیستماتیک به وسیله اعداد حاصل از کامپیوتر و با استفاده از نرم افزار آنلاین گراف پد با در نظر گرفتن 2 گروه 40 نفره (مداخله و کنترل) توسط شخص مستقل انجام گرفت.

  • Ethics committees

    #1
    IR.TBZMED. REC. 1398. 713
    IR.TBZMED.REC.1398.713

  • Intervention groups

    #1
    Intervention group: intervention group will recieve 1000 mg of metformin before thrombolytic, then metformin 500 mg twice daily for 3 days with standard treatments
    Intervention group: intervention group will recieve 1000 mg of metformin before thrombolytic with standard treatments
    گروه مداخله: گروه مداخله ۱۰۰۰ میلی گرم متفورمین قبل ترومبولایتیک تراپی سپس روزی دو بار متفورمین ۵۰۰ میلی گرم به مدت ۳ روز در کنار درمانهای معمول دریافت خواهندکرد
    گروه مداخله: گروه مداخله ۱۰۰۰ میلی گرم متفورمین قبل ترومبولایتیک تراپی کنار درمانهای معمول دریافت خواهندکرد

  • Recruitment centers

    #1
    Name of recruitment center - English: Shahid Madani Heart Center of Tabriz
    Name of recruitment center - Persian: مرکز قلب شهید مدنی تبریز
    Full name of responsible person - English: Dr. Taher Entezari-Maleki
    Full name of responsible person - Persian: دکتر طاهر انتظاری ملکی
    Street address - English: Shahid Madani Heart Center, Daneshghah Street
    Street address - Persian: خیابان دانشگاه، مرکز قلب شهید مدنی
    City - English: TABRIZ
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: -
    Phone: +98 41 3337 3901
    Fax:
    Email: tentezari@gmail.com
    Web page address:
    Name of recruitment center - English: Shahid Madani Heart Center of Tabriz
    Name of recruitment center - Persian: مرکز قلب شهید مدنی تبریز
    Full name of responsible person - English: Dr. Taher Entezari-Maleki
    Full name of responsible person - Persian: دکتر طاهر انتظاری ملکی
    Street address - English: Shahid Madani Heart Center, Daneshghah Street
    Street address - Persian: خیابان دانشگاه، مرکز قلب شهید مدنی
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: -
    Phone: +98 41 3337 3901
    Fax:
    Email: tentezari@gmail.com
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr.Mohammad Reza Rashidi
    Full name of responsible person - Persian: آقای دکتر محمدرضا رشیدی
    Street address - English: Daneshghah street,Golgasht
    Street address - Persian: تبریز خیابان دانشگاه,گلگشت
    City - English: tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 3335710
    Phone: +98 41 3335 7310
    Fax:
    Email: tentezari@gmail.com
    Web page address: https://researchvice.tbzmed.ac.ir

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr.Mohammad Reza Rashidi
    Full name of responsible person - Persian: آقای دکتر محمدرضا رشیدی
    Street address - English: Daneshghah street,Golgasht
    Street address - Persian: تبریز خیابان دانشگاه,گلگشت
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 3335710
    Phone: +98 41 3335 7310
    Fax:
    Email: tentezari@gmail.com
    Web page address: https://researchvice.tbzmed.ac.ir

Protocol summary

Study aim
Evaluation of the effect of metformin on cardiac troponin-I in STEMI patients treated with thrombolytic therapy
Design
Randomized Control Trials, Double blind
Settings and conduct
This is a prospective, randomized controlled trial on a total of 80 consented patients older than 18 years with thrombolytic therapy who attended the Shahid Madani clinic of Tabriz University of Medical Science.intervention group will recieve اn addition to routine treatment, 1000 mg of metformin before thrombolytic.Patients in the control group will receive only routine treatment.The blood level of cTnI will be checkedevery 8 hours for 48_72 hours in two groups with and without metformin.
Participants/Inclusion and exclusion criteria
Inclusion:Ischemic heart diseases ; age 18-80; undergoing of thrombolytic therapy; filling of consent form Exclusion:Elevation of troponin I- (above normal) at least 48 hours before thrombolytic therapy; history of CABG during last three months; history of previous MI; renal failure (creatinine clearance below 30 mg / dl or creatinine above 1 /4 in women and 1/5 in men);sensitivity to aspirin or clopidogrel and retaplase; cardiogenic shock; history of end-stage renal failure or dialysis; presence of metformin inhibition
Intervention groups
intervention group will recieve اn addition to routine treatment, 1000 mg of metformin before thrombolytic.Patients in the control group will receive only routine treatment.
Main outcome variables
Comparison of cTnI enzyme levels in STEMI patients in the two groups studied.

General information

Reason for update
The number of people decreased due to Corona virus.
Acronym
IRCT registration information
IRCT registration number: IRCT20111206008307N34
Registration date: 2020-06-02, 1399/03/13
Registration timing: registered_while_recruiting

Last update: 2021-01-18, 1399/10/29
Update count: 1
Registration date
2020-06-02, 1399/03/13
Registrant information
Name
Taher Entezari-Maleki
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4709
Email address
tentezarimaleki@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-05, 1398/10/15
Expected recruitment end date
2020-09-19, 1399/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of metformin on cardiac troponin-I in STEMI patients treated with thrombolytic therapy
Public title
Evaluation of the effect of metformin in STEMI patients treated with thrombolytic therapy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Ischemic heart diseases age 18-80 undergoing of thrombolytic therapy filling of consent form
Exclusion criteria:
Elevation of troponin I- (above normal) at least 48 hours before thrombolytic therapy history of CABG during last three months history of previous MI; renal failure (creatinine clearance below 30 mg / dl or creatinine above 1 /4 in women and 1/5 in men) sensitivity to aspirin or clopidogrel and retaplase cardiogenic shock; history of end-stage renal failure or dialysis presence of metformin inhibition
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done using computer generated random number (systematic randomization) by online Graphpad software by determining 2 study groups and 40 patients in each group (Control and Intervention) by an independent person.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Tabriz Univercity of Medical Science
Street address
Reasearch and Technology Deputy, Tabriz University of Medical Science, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2019-10-13, 1398/07/21
Ethics committee reference number
IR.TBZMED.REC.1398.713

Health conditions studied

1

Description of health condition studied
Ischemic heart diseases patients
ICD-10 code
I20, I21,
ICD-10 code description
ischemic heart diseases

Primary outcomes

1

Description
cTnI level
Timepoint
BASELINE،8،16، 24 AND 32 HOURS AFTER Thrombolytic
Method of measurement
ELISA

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: intervention group will recieve 1000 mg of metformin before thrombolytic with standard treatments
Category
Treatment - Drugs

2

Description
Control group:Control group will only recieve standard treatments
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Madani Heart Center of Tabriz
Full name of responsible person
Dr. Taher Entezari-Maleki
Street address
Shahid Madani Heart Center, Daneshghah Street
City
Tabriz
Province
East Azarbaijan
Postal code
-
Phone
+98 41 3337 3901
Email
tentezari@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Mohammad Reza Rashidi
Street address
Daneshghah street,Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
3335710
Phone
+98 41 3335 7310
Email
tentezari@gmail.com
Web page address
https://researchvice.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Taher Entezari-Maleki
Position
Assistant professor/ Clinical pharmacist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Daneshghah Street
City
Tabriz
Province
East Azarbaijan
Postal code
+98 41 3334 4798
Phone
+98 41 1339 2593
Fax
+98 41 1334 4798
Email
tentezari@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Taher Entezari-maleki
Position
Assistant professor/ Clinical pharmacist
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
Faculty of pharmacy, Daneshgah Street
City
Tabriz
Province
East Azarbaijan
Postal code
+98 41 3334 4798
Phone
+98 41 1339 2593
Email
tentezari@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Taher Entezari-Maleki
Position
Assistant professor/Clinical pharmacist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Daneshgah Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 1339 2593
Email
tentezari@gmail.com

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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All of the data of an article can be published after making patients unrecognized
When the data will become available and for how long
After publishing of article until 6 months after publishing of the results
To whom data/document is available
Data will be available to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Researchers that request data will be permitted only to doing analysis according to ethics for scientific aims
From where data/document is obtainable
Applicants can receive data by sending an E-mail to address of tentezari@gmail.com and get response from Dr. Taher Entezari Maleki
What processes are involved for a request to access data/document
After contacting with corresponding author(Dr.Taher Entezari Maleki), data will be sent to Tabriz Shahid Madani hospital ethics committee and after receiving permission data will be send to applicants
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