IRCT | The effect of colchicine on reperfusion arrhythmias in ST-elevation myocardial infarction (STEMI) patients treated with Primary Percutaneous Coronary Intervention (PPCI)

Protocol summary

Study aim: Investigating the effect of colchicine on arrhythmia reperfusion in acute myocardial infarction patients undergoing Primary Percutaneous Coronary Intervention (PPCI)
Design: A clinical trial with a control group, with parallel groups, double-blind, randomized using random numbers, the intended sample size in two intervention and control groups is a total of 154 people.
Settings and conduct: Patients with STEMI referred to Bo Ali Qazvin Hospital who are candidates for PPCI are included in the study. Colchicine is administered to the intervention group before PPCI and placebo to the control group. The administration of colchicine will be in such a way that PPCI candidate patients will receive 2 grams of colchicine as STAT before PCI, and 0.5 mg of colchicine will be prescribed every twelve hours from the second day for 5 days.
Participants/Inclusion and exclusion criteria: All patients with STEMI who are candidates for PPCI
Intervention groups: Intervention group: people receiving colchicine Control group: people receiving placebo
Main outcome variables: - Angiographic findings of PPCI include initial and final TIMI of the involved vessel - The occurrence or non-occurrence of arrhythmia after reperfusion and the type of reperfusion arrhythmia if it occurs

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20220723055534N1

Registration date: 2023-04-12, 1402/01/23

Registration timing: registered_while_recruiting

Last update: 2023-04-12, 1402/01/23

Update count: 0
Registration date: 2023-04-12, 1402/01/23

Registrant information: Name

Seyed Amir Reza Mohajeri

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 28 3333 2930

Email address

a.mohajeri@qums.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2022-08-27, 1401/06/05
Expected recruitment end date: 2023-08-27, 1402/06/05
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: The effect of colchicine on reperfusion arrhythmias in ST-elevation myocardial infarction (STEMI) patients treated with Primary Percutaneous Coronary Intervention (PPCI)

Public title: Colchicine in myocardial infarction
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Patients with STEMI that are candidates for PPCI

Exclusion criteria:

Patients who previously used Colchicine or Prednisolone for any reason Contraindications of Colchicine, including sensitivity to Colchicine, kidney failure (GFR < 10), liver failure (AST - ALT above 5 times normal) and definite history of serious liver diseases (such as hepatitis, hemochromatosis, Wilson's disease, cirrhosis) Drugs that interact with risk X with colchicine
Age: No age limit
Gender: Both

Phase

3

Groups that have been masked

Participant
Care provider
Outcome assessor

Sample size

Target sample size: 154

Randomization (investigator's opinion)

Randomized

Randomization description

Patients are divided into 2 groups. The division of people between two groups will be in a double-blind manner, and the type of randomization will be by Block randomization method, after the exit of people with exclusion criteria. The method of performing randomization is in such a way that at first, the number of samples will be given to the Random Allocation Software version 1.0.0. In the next step, it will be determined that each number will be placed in which study group, and the main drug or placebo will be placed in the drug package of that code. When patients admitted to the medical center, drug packages are prescribed for them in the order of number.

Blinding (investigator's opinion)

Double blinded

Blinding description

In this study, the following people are blinded to the study groups: - Patients included in the study - Nurses who give colchicine or placebo to patients. - Cardiologist who performs PPCI for patients and report angiography results. - Nurses and researchers who evaluate the incidence of arrhythmia in patients. Considering that the packaging of medicines and numbering on the medicine packages will be done by other people and all the medicine packages are similar, none of the groups mentioned above have any knowledge of the type of medicine prescribed for the patient. . In the data analysis stage, the code of drug packages and their contents will be entered in the database file and the analysis will be done based on the type of drug.

Placebo

Used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Research Ethics Committees of Qazvin University of Medical Sciences

Street address

Qazvin University of Medical Sciences, Shahid Bahonar Boulevard, Qazvin

City

Qazvin

Province

Qazvin

Postal code

5981134197
Approval date: 2022-07-02, 1401/04/11
Ethics committee reference number: IR.QUMS.REC.1401.102

Health conditions studied

1

Description of health condition studied: ST-elevation myocardial infarction
ICD-10 code: I21
ICD-10 code description: ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction

2

Description of health condition studied: Cardiac arrhythmia
ICD-10 code: I49
ICD-10 code description: Other cardiac arrhythmias

Primary outcomes

1

Description: The incidence of cardiac arrhythmia
Timepoint: The first day after the occurrence of STEMI
Method of measurement: Checking the rhythm recorded in the 24-hour monitor of the patient

2

Description: Cardiac arrhythmia type in the first 24 hours after PPCI
Timepoint: The first day after the occurrence of STEMI
Method of measurement: Checking the rhythm recorded in the 24-hour monitor of the patient

3

Description: Comparison of initial and final TIMI of involved vessels
Timepoint: At the beginning and end of coronary angiography
Method of measurement: Based on the standard specified in Branwald's cardiology book, the division is done

Secondary outcomes

empty

Intervention groups

1

Description: Intervention group: STEMI patients who are candidates for PPCI, before PCI, receive 2 grams of colchicine as STAT, and from the second day, 0.5 mg of colchicine will be prescribed every twelve hours for 5 days.
Category: Treatment - Drugs

2

Description: Control group: These patients are candidates for PPCI, but they will receive placebo instead of colchicine.
Category: Placebo

Recruitment centers

1

Recruitment center: Name of recruitment center

Buali Hospital

Full name of responsible person

Majid Hajikarimi

Street address

Buali Ave.

City

Qazvin

Province

Qazvin

Postal code

3413786165

Phone

+98 28 3333 2930

Email

s.a.r.mohajery@gmail.com

1

Sponsor: Name of organization / entity

Qazvin University of Medical Sciences

Full name of responsible person

Seyed Mahdi Mirhashemi

Street address

first branch, Maudet Alley, Shahid Beheshti Blvd.

City

Qazvin

Province

Qazvin

Postal code

3415613911

Phone

+98 28 3333 7006

Email

researchdpt@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Qazvin 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

Qazvin University of Medical Sciences

Full name of responsible person

Majid Hajikarimi

Position

Assistant Professor

Latest degree

Subspecialist

Other areas of specialty/work

Cardiology

Street address

Buali Hospital, Buali ave.

City

Qazvin

Province

Qazvin

Postal code

3413786165

Phone

+98 28 3333 2930

Fax

Email

majidhajikarimi57@gmail.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Qazvin University of Medical Sciences

Full name of responsible person

Majid Hajikarimi

Position

Assistant Professor

Latest degree

Subspecialist

Other areas of specialty/work

Cardiology

Street address

Buali Hospital, Buali ave.

City

Qazvin

Province

Qazvin

Postal code

3413786165

Phone

+98 28 3333 2930

Fax

Email

majidhajikarimi57@gmail.com

Person responsible for updating data

Contact: Name of organization / entity

Qazvin University of Medical Sciences

Full name of responsible person

Seyed Amir Reza Mohajeri

Position

Resident

Latest degree

Medical doctor

Other areas of specialty/work

Cardiology

Street address

Buali Hospital, Buali ave.

City

Qazvin

Province

Qazvin

Postal code

3413786165

Phone

+98 28 3333 2930

Fax

Email

s.a.r.mohajery@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: 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: The entire data of this study will be shared based on the request of the journal in which the article of this study will be published after de-identifying the individuals.
When the data will become available and for how long: After publishing the results and printing the article
To whom data/document is available: All people who need the data of this study
Under which criteria data/document could be used: ---
From where data/document is obtainable: Seyed Amir Reza Mohajeri a.mohajeri@qums.ac.ir s.a.r.mohajery@gmail.com Majid Hajikarimi majidhajikarimi57@gmail.com
What processes are involved for a request to access data/document: After receiving the applicant's request, this request will be submitted to the research assistant of Qazvin University of Medical Sciences, and if approved by this assistant, the information will be sent. This process will take about 2 weeks to a month.
Comments

The effect of colchicine on reperfusion arrhythmias in ST-elevation myocardial infarction (STEMI) patients treated with Primary Percutaneous Coronary Intervention (PPCI)