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Evaluation of the effect of loading dose of vitamin D before percutaneous coronary intervention in patients with unstable angina in reducing Major adverse cardiovascular events

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History
# Registration date Revision Id
2 2022-10-25, 1401/08/03 244082
1 2021-10-22, 1400/07/30 202453
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  • Protocol summary

    Evaluation of the effect of loading dose of vitamin D before percutaneous coronary intervention(PCI) in patients with acute coronary syndrome(ACS) in reducing Major adverse cardiovascular events(MACE)
    Evaluation of the effect of loading dose of vitamin D before percutaneous coronary intervention(PCI) in patients with unstable angina(UA) in reducing Major adverse cardiovascular events(MACE)
    تعیین تاثیر تجویز دوز اولیه ویتامین D قبل از انجام آنژیوپلاستی در بیماران مبتلا به سندرم حاد کرونری در کاهش عوارض ماژور قلبی و عروقی
    تعیین تاثیر تجویز دوز اولیه ویتامین D قبل از انجام آنژیوپلاستی در بیماران مبتلا به آنژین ناپایدار در کاهش عوارض ماژور قلبی و عروقی
    In patients with acute coronary syndrome(ACS) who are candidates for percutaneous coronary intervention(PCI) and are admitted to Ayatollah Mousavi Hospital during 2021, a venous blood sample will be taken before PCI to measure vitamin D levels. Patients with serum vitamin D deficiency(Less than 30ng/ml) underwent telephone and in-person follow-up in the form of history, physical examination, ECG and echocardiography during 3 and 6 months after PCI, and in terms of the occurrence of Major adverse cardiovascular events(MACE) including myocardial infarction, cerebrovascular events, need for revascularization, hospitalization, and mortality are monitored. finally, the frequency of MACE and its components are compared between the two groups.
    In patients with unstable angina(UA) who are candidates for percutaneous coronary intervention(PCI) and are admitted to Ayatollah Mousavi Hospital during 2021, a venous blood sample will be taken before PCI to measure vitamin D levels. Patients with serum vitamin D deficiency(Less than 30ng/ml) underwent telephone and in-person follow-up in the form of history, physical examination, ECG and echocardiography during 3 and 6 months after PCI, and in terms of the occurrence of Major adverse cardiovascular events(MACE) including myocardial infarction, re hospitalization, need for revascularization in re hospitalization and mortality are monitored. finally, the frequency of MACE and its components are compared between the two groups.
    در بیماران مبتلا به سندرم حاد کرونری کاندید انجام آنژیوپلاستی که طی سال 1400 در بیمارستان آیت الله موسوی بستری می شوند، پیش از انجام آنژیوپلاستی، نمونه ی خون وریدی برای اندازه گیری سطح ویتامین D اخذ خواهد شد. بیمارانی که کمبود سطح سرمی ویتامین D دارند(کمتر از 30نانوگرم بر میلی لیتر)، طی 3 و 6 ماه بعد از انجام آنژیوپلاستی، تحت پیگیری تلفنی و پیگیری حضوری به صورت اخذ شرح حال، معاینه فیزیکی، اخذ نوار قلب و انجام اکوکاردیوگرافی قرار گرفته و از لحاظ وقوع Major adverse cardiovascular events (MACE) شامل انفارکتوس میوکارد، حوادث عروق مغزی، نیاز به رواسکولاریزاسیون، بستری در بیمارستان و مرگ و میر مورد پیگیری قرار گرفته و در نهایت، فراوانی MACE و اجزای آن بین دو گروه مورد مقایسه قرار می گیرد.
    در بیماران مبتلا به آنژین ناپایدار کاندید انجام آنژیوپلاستی که طی سال 1400 در بیمارستان آیت الله موسوی بستری می شوند، پیش از انجام آنژیوپلاستی، نمونه ی خون وریدی برای اندازه گیری سطح ویتامین D اخذ خواهد شد. بیمارانی که کمبود سطح سرمی ویتامین D دارند(کمتر از 30نانوگرم بر میلی لیتر)، طی 3 و 6 ماه بعد از انجام آنژیوپلاستی، تحت پیگیری تلفنی و پیگیری حضوری به صورت اخذ شرح حال، معاینه فیزیکی، اخذ نوار قلب و انجام اکوکاردیوگرافی قرار گرفته و از لحاظ وقوع Major adverse cardiovascular events (MACE) شامل انفارکتوس میوکارد، بستری مجدد، نیاز به رواسکولاریزاسیون در بستری مجدد و مرگ و میر مورد پیگیری قرار گرفته و در نهایت، فراوانی MACE و اجزای آن بین دو گروه مورد مقایسه قرار می گیرد.
    Patients over 18 years of age with acute coronary syndrome and candidates for percutaneous coronary intervention(PCI) with serum vitamin D deficiency will be deliberately admitted to the study. Patients with a history of myocardial infarction, revascularization or CABG will be excluded from the study.
    Patients over 18 years of age with unstable angina and candidates for percutaneous coronary intervention(PCI) with serum vitamin D deficiency will be deliberately admitted to the study. Patients with a history of myocardial infarction, revascularization or CABG will be excluded from the study.
    بیماران بالای 18 سال، مبتلا به سندرم حاد کرونری که کاندید آنژیوپلاستی می باشند و دچار کمبود سطح سرمی ویتامین D می باشند، وارد مطالعه خواهند شد. بیماران با سابقه ی قبلی انفارکتوس میوکارد، رواسکولاریزاسیون یا جراحی باز قلبی از مطالعه خارج خواهند شد.
    بیماران بالای 18 سال، مبتلا به آنژین ناپایدار که کاندید آنژیوپلاستی می باشند و دچار کمبود سطح سرمی ویتامین D می باشند، وارد مطالعه خواهند شد. بیماران با سابقه ی قبلی انفارکتوس میوکارد، رواسکولاریزاسیون یا جراحی باز قلبی از مطالعه خارج خواهند شد.
    Myocardial infarction; Cerebrovascular events; Need for revascularization; Hospitalization; mortality
    Myocardial infarction; re hospitalization; need for revascularization in re hospitalization; mortality
    انفارکتوس میوکارد ؛ حوادث عروق مغزی ؛ نیاز به رواسکولاریزاسیون ؛ بستری در بیمارستان ؛ مرگ و میر
    انفارکتوس میوکارد ؛ بستری مجدد ؛ نیاز به رواسکولاریزاسیون در بستری مجدد ؛ مرگ و میر

  • General information

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    76
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    2021-10-24, 1400/08/02
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    2022-04-19, 1401/01/30
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    2022-10-22, 1401/07/30
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    Edited by the Hospital Research Committee
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    ویرایش توسط کمیته پژوهشی بیمارستان
    Evaluation of the effect of loading dose of vitamin D before percutaneous coronary intervention in patients with acute coronary syndrome in reducing Major adverse cardiovascular events
    Evaluation of the effect of loading dose of vitamin D before percutaneous coronary intervention in patients with unstable angina in reducing Major adverse cardiovascular events
    بررسی تاثیر تجویز دوز اولیه ویتامین دی قبل از انجام مداخله کرونری به روش زیرپوستی در بیماران مبتلا به سندرم حاد کرونری در کاهش عوارض ماژور قلبی و عروقی
    بررسی تاثیر تجویز دوز اولیه ویتامین دی قبل از انجام مداخله کرونری به روش زیرپوستی در بیماران مبتلا به آنژین ناپایدار در کاهش عوارض ماژور قلبی و عروقی
    Patients with acute coronary syndrome (first episode) who are candidates for PCI
    Patients with deficient serum levels of vitamin D
    Patients with unstable angina who are candidates for PCI
    Patients with deficient serum levels of vitamin D
    بیماران مبتلا به سندرم حاد کرونری (اولین اپیزود) که کاندید انجام PCI می باشند
    بیمارانی که کمبود سطح سرمی ویتامین D دارند
    بیماران مبتلا به آنژین ناپایدار که کاندید انجام PCI می باشند
    بیمارانی که کمبود سطح سرمی ویتامین D دارند
    Previous history of myocardial infarction
    Previous history of revascularization therapy interventions
    Patients with acute myocardial infarction
    Patients admitted with a diagnosis of NSTEMI
    Patients with a previous history of CABG
    Patients with failed PCI
    Simultaneous involvement of valvular disorders
    Take vitamin D, calcium or omega-3 supplements in the last 3 months
    Patients with hypercalcemia, nephrolithiasis, sarcoidosis, malabsorption syndromes
    Chronic underlying diseases such as liver, kidney or rheumatic disorders
    Pregnancy and lactation
    Having malignancies
    History of receiving corticosteroids or immunosuppressants in the last 6 months
    Previous history of myocardial infarction
    Previous history of revascularization therapy interventions
    Patients with a previous history of CABG
    Patients with failed PCI
    Simultaneous involvement of valvular disorders
    Take vitamin D, calcium or omega-3 supplements in the last 3 months
    Patients with hypercalcemia, nephrolithiasis, sarcoidosis, malabsorption syndromes
    Chronic underlying diseases such as liver, kidney or rheumatic disorders
    Pregnancy and lactation
    Having malignancies
    History of receiving corticosteroids or immunosuppressants in the last 6 months
    سابقه ی قبلی انفارکتوس میوکارد
    سابقه ی قبلی مداخلات درمانی رواسکولاریزاسیون
    بیماران مبتلا به انفارکتوس حاد قلبی
    بیماران بستری شده با تشخیص NSTEMI
    بیماران با سابقه قبلی CABG
    بیماران با PCI ناموفق
    ابتلای همزمان به اختلالات دریچه ای
    دریافت مکمل های ویتامین D، کلسیم و یا امگا سه طی 3 ماه اخیر
    بیماران مبتلا به هیپرکلسمی، نفرولیتیازیس، سارکوئیدوز، سندرم های سوء جذب
    بیماری های مزمن زمینه ای از قبیل اختلالات کبدی، کلیوی و یا روماتولوژیک
    بارداری و شیردهی
    ابتلا به بدخیمی ها
    سابقه ی دریافت داروهای کورتیکواستروییدی و یا سرکوبگر ایمنی طی 6 ماه اخیر
    سابقه ی قبلی انفارکتوس میوکارد
    سابقه ی قبلی مداخلات درمانی رواسکولاریزاسیون
    بیماران با سابقه قبلی CABG
    بیماران با PCI ناموفق
    ابتلای همزمان به اختلالات دریچه ای
    دریافت مکمل های ویتامین D، کلسیم و یا امگا سه طی 3 ماه اخیر
    بیماران مبتلا به هیپرکلسمی، نفرولیتیازیس، سارکوئیدوز، سندرم های سوء جذب
    بیماری های مزمن زمینه ای از قبیل اختلالات کبدی، کلیوی و یا روماتولوژیک
    بارداری و شیردهی
    ابتلا به بدخیمی ها
    سابقه ی دریافت داروهای کورتیکواستروییدی و یا سرکوبگر ایمنی طی 6 ماه اخیر

  • Health conditions studied

    #1
    Acute coronary syndrome
    Unstable angina
    سندرم حاد کرونری
    آنژین ناپایدار

  • Primary outcomes

    #1
    Number of revascularization cases
    Number of revascularization cases in re hospitalization
    تعداد موارد رواسکولاریزاسیون
    تعداد موارد رواسکولاریزاسیون در بستری مجدد

  • Secondary outcomes

    #1
    The rate of cerebrovascular accidents
    Cardiac function
    میزان حوادث عروق مغزی
    عملکرد قلبی
    In-person and telephone follow-up
    In-person follow-up
    پیگیری حضوری و تلفنی
    پیگیری حضوری

Protocol summary

Study aim
Evaluation of the effect of loading dose of vitamin D before percutaneous coronary intervention(PCI) in patients with unstable angina(UA) in reducing Major adverse cardiovascular events(MACE)
Design
In this Single Blind Trial, 76 patients with serum vitamin D deficiency who are candidates for percutaneous coronary intervention(PCI) are randomly divided into two parallel groups.
Settings and conduct
In patients with unstable angina(UA) who are candidates for percutaneous coronary intervention(PCI) and are admitted to Ayatollah Mousavi Hospital during 2021, a venous blood sample will be taken before PCI to measure vitamin D levels. Patients with serum vitamin D deficiency(Less than 30ng/ml) underwent telephone and in-person follow-up in the form of history, physical examination, ECG and echocardiography during 3 and 6 months after PCI, and in terms of the occurrence of Major adverse cardiovascular events(MACE) including myocardial infarction, re hospitalization, need for revascularization in re hospitalization and mortality are monitored. finally, the frequency of MACE and its components are compared between the two groups.
Participants/Inclusion and exclusion criteria
Patients over 18 years of age with unstable angina and candidates for percutaneous coronary intervention(PCI) with serum vitamin D deficiency will be deliberately admitted to the study. Patients with a history of myocardial infarction, revascularization or CABG will be excluded from the study.
Intervention groups
Patients were randomly divided into two groups before the intervention, so that the first group, in addition to routine drugs, treated with vitamin D (300,000 units orally 12 hours before PCI), and the second group will receive only routine medications.
Main outcome variables
Myocardial infarction; re hospitalization; need for revascularization in re hospitalization; mortality

General information

Reason for update
Edited by the Hospital Research Committee
Acronym
IRCT registration information
IRCT registration number: IRCT20210228050528N1
Registration date: 2021-10-22, 1400/07/30
Registration timing: prospective

Last update: 2022-10-29, 1401/08/07
Update count: 1
Registration date
2021-10-22, 1400/07/30
Registrant information
Name
Amir Shahbazzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6653 5168
Email address
amirshahbazzadeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
2021-10-24, 1400/08/02
Actual recruitment end date
2022-04-19, 1401/01/30
Trial completion date
2022-10-22, 1401/07/30
Scientific title
Evaluation of the effect of loading dose of vitamin D before percutaneous coronary intervention in patients with unstable angina in reducing Major adverse cardiovascular events
Public title
Evaluation of the effect of vitamin D before percutaneous coronary intervention in the prevention of cardiovascular complications
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with unstable angina who are candidates for PCI Patients with deficient serum levels of vitamin D
Exclusion criteria:
Previous history of myocardial infarction Previous history of revascularization therapy interventions Patients with a previous history of CABG Patients with failed PCI Simultaneous involvement of valvular disorders Take vitamin D, calcium or omega-3 supplements in the last 3 months Patients with hypercalcemia, nephrolithiasis, sarcoidosis, malabsorption syndromes Chronic underlying diseases such as liver, kidney or rheumatic disorders Pregnancy and lactation Having malignancies History of receiving corticosteroids or immunosuppressants in the last 6 months
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 76
Actual sample size reached: 76
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients are divided into simple randomizations using randomly generated computer-generated numbers by an independent individual.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, patients will be unaware of the nature of the prescribed drug, that is, after randomly dividing patients into two groups, the first group in addition to routine pre-intervention drugs, treated with vitamin D (three hundred thousand units orally 12 Hours before the intervention), and the second group will receive only routine pre-intervention medications.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Zanjan University of Medical Sciences
Street address
Ayatollah Mousavi Hospital, Gavazang Boulevard
City
Zanjan
Province
Zanjan
Postal code
4513956183
Approval date
2021-09-01, 1400/06/10
Ethics committee reference number
IR.ZUMS.REC.1400.218

Health conditions studied

1

Description of health condition studied
Major adverse cardiovascular events
ICD-10 code
R94.30
ICD-10 code description
Abnormal result of cardiovascular function study, unspecified

2

Description of health condition studied
Precutaneous coronary intervention
ICD-10 code
Z95.5
ICD-10 code description
Presence of coronary angioplasty implant and graft

3

Description of health condition studied
Unstable angina
ICD-10 code
I25.110
ICD-10 code description
Atherosclerotic heart disease of native coronary artery with unstable angina pectoris

Primary outcomes

1

Description
Number of myocardial infarction cases
Timepoint
3 and 6 months later
Method of measurement
ECG and echocardiography

2

Description
Number of revascularization cases in re hospitalization
Timepoint
3 and 6 months later
Method of measurement
ECG and echocardiography

Secondary outcomes

1

Description
Readmission rate
Timepoint
3 and 6 months later
Method of measurement
ECG and echocardiography

2

Description
Mortality rate
Timepoint
3 and 6 months later
Method of measurement
In-person and telephone follow-up

3

Description
Cardiac function
Timepoint
3 and 6 months later
Method of measurement
In-person follow-up

Intervention groups

1

Description
Intervention group: A group that, in addition to routine pre-PCI medications, is treated with 300,000 units of oral vitamin D (six 50,000 units of vitamin D tablets produced by Zahravi Pharmaceutical Company) 12 hours before PCI.
Category
Treatment - Drugs

2

Description
Control group: The group that only receives routine medications before PCI.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Mousavi Hospital
Full name of responsible person
Amir shahbazzadeh
Street address
Gavazang Boulevard
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
Mousavihospital@zums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Alireza shoghli
Street address
Gavazang Boulevard
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
Mousavihospital@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Amir Shahbazzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
No 232, block C, Honarmandan tower, Shariati Blvd, Zanjan
City
Zanjan
Province
Zanjan
Postal code
5819463168
Phone
+98 21 6653 5168
Fax
Email
amirshahbazzadeh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Amir Shahbazzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
No 232, block C, Honarmandan tower, Shariati Blvd, Zanjan
City
Zanjan
Province
Zanjan
Postal code
5819463168
Phone
+98 21 6653 5168
Fax
Email
amirshahbazzadeh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Amir Shahbazzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Cardiology
Street address
No 232, block C, Honarmandan tower, Shariati Blvd, Zanjan
City
Zanjan
Province
Zanjan
Postal code
5819463168
Phone
+98 21 6653 5168
Fax
Email
amirshahbazzadeh@yahoo.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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data, such as information about the primary or secondary outcome, will be shared.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers in academic and scientific institutions
Under which criteria data/document could be used
The data and documents of the study will be available for the use of other researchers in academic and scientific institutions in relation to related topics with ethical principles.
From where data/document is obtainable
My e-mail address : Amirshahbazzadeh@yahoo.com
What processes are involved for a request to access data/document
The applicant can access the study data and documents after submitting the requirement on reputable sites and online correspondence with me.
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