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IRCT20231223060504N1 IRCT 2024-01-16 Tabriz University of Medical Sciences Investigating the effect of colchicine on left ventricular function based on conventional and strain echocardiography Effect of low dose cholchicine on LV function after myocardial infarction based on usual and strain echocardiography 2023-12-31 anticipated 96 Complete https://irct.ir/trial/74590 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 96 patients are divided into intervention and control groups by using the creation of random numbers by Excel software (48 patients in each group), randomization is done in a simple way and is done in the individual randomization unit. The randomization tool is a table of numbers. Random numbers are generated in 2 groups A and B, the numbers of group A are used for the intervention group and the numbers of group B are used for the control group according to the randomly created sequence, and finally each patient (according to the time of hospitalization) may be in each of be placed in 2 groups.According to the randomly created number, medical personnel and patients are not aware of the type of pills they receive, only the researcher is aware of it based on the code inserted on the pill box, so this study is a double-blind clinical trial. 48 patients in each treatment arm are randomly assigned to receive placebo or colchicine, Blinding description: Patients were told that they could receive colchicine or placebo. Therefore, patients are not aware of their treatment group. Patients and medical personnel do not know the type of pills that are in the boxes (colchicine or placebo). Only the researcher is aware of it based on the code inserted on the pill box, so this study is a double-blind parallel clinical trial study.The drug and placebo are completely similar in terms of shape, size and color, so blinding at the participant level will be done well. 3 Acute anterior STEMI. Intervention 1: A total of 966 tablets (the total number of tablets required for distribution among the intervention group) of Colchicine 1 mg manufactured by Sinapishgam Daru Novin Company will be prepared. Each patient will be given 21 tablets to use half a tablet daily for 42 days (6 weeks). Intervention 2: 966 placebo pills (the total number of pills needed to be distributed among the control group) are made for use in 48 patients of the control group in the pharmaceutical laboratory of Tabriz Faculty of Pharmacy, and starch and magnesium stearate are used as lubricants. In terms of shape, color and size, it is exactly the same as colchicine tablets of Sinapishgam Daro Navin company. Each control group patient is given 21 tablets (placebo) to use half a tablet daily for 42 days (6 weeks). Yes - There is a plan to make this available What will be shared: Part of the data, such as information about the main outcome When: 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: The use of the data of this study will be allowed for researchers and scientific personalities. Where to obtain: Dr. Niloofar Salari salari.niloofar@ymail.com 09132489115 Tabriz Shahid Madani Hospital Research Center How to obtain: Applicants will be able to receive the data of this study by visiting or contacting the research center of Tabriz Shahid Madani Hospital. Comments:
public Niloofar Salari
No. 7, Golgasht, Shahid Madani Hospital
Tabriz Iran (Islamic Republic of) 5165747635 +98 41 4333 3900 salari.niloofar@ymail.com Tabriz University of Medical Sciences scientific Niloofar Salari
Golbad
Tabriz Iran (Islamic Republic of) 5165747635 +98 34 4333 3900 salari.niloofar@ymail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) All patients with acute anterior STEMI will be included in the study. no limit no limit Both stroke in the last 3 months Type 2 Index MI CABG in the last 3 years or decision to undergo surgery History of non-skin malignancies in the last 3 years Inflammatory bowel disease (IBD) Chronic diarrhea Neuromuscular diseases with a CK level greater than 3 times the maximum normal (except for diseases that have led to muscle infarction) Chronic hematological diseases Current treatment with corticosteroids or other anti-inflammatory drugs Known sensitivity to colchicine or current chronic treatment with Colchicine Severe kidney failure (Cr>2 upper limit of the normal range) Severe liver failure History of alcohol or drug abuse I21.0 ST elevation (STEMI) myocardial infarction of anterior wall Treatment - Drugs Placebo A total of 966 tablets (the total number of tablets required for distribution among the intervention group) of Colchicine 1 mg manufactured by Sinapishgam Daru Novin Company will be prepared. Each patient will be given 21 tablets to use half a tablet daily for 42 days (6 weeks). 966 placebo pills (the total number of pills needed to be distributed among the control group) are made for use in 48 patients of the control group in the pharmaceutical laboratory of Tabriz Faculty of Pharmacy, and starch and magnesium stearate are used as lubricants. In terms of shape, color and size, it is exactly the same as colchicine tablets of Sinapishgam Daro Navin company. Each control group patient is given 21 tablets (placebo) to use half a tablet daily for 42 days (6 weeks). Left ventricle function. Timepoint: The effect of colchicine on left ventricular function at the beginning of the study (before the start of the intervention) and 4 to 6 weeks after administration. Method of measurement: Echocardiography machine. Tabriz University of Medical Sciences Approved 2023-11-25 Ethics committee of Tabriz University of Medical Sciences Golgasht Tabriz East Azarbaijan Iran (Islamic Republic of)