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IRCT20231015059731N1 IRCT 2023-11-27 Khoram-Abad University of Medical Sciences The effect of colchicine on reducing myocardial injury The effect of colchicine on reducing myocardial injury caused by coronary angioplasty procedure in patients with coronary artery disease 2023-10-23 anticipated 210 Complete https://irct.ir/trial/73212 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Allocation of samples in groups is done using block randomization method and patients are placed in 2 study groups in a balanced way by block randomization method, Blinding description: The patients in both intervention and control groups have no information regarding receiving or not receiving placebo. Also, the doctor of Intervention has no information regarding which study group the patient undergoing angioplasty is in. 3 Coronary artery disease with angina pectoris. Intervention 1: Intervention group: In the intervention group, patients will first receive 1 mg of colchicine (produced by Hashtgerd-Iran Mofid Pharmaceutical Company) 12 to 24 hours before the study and half a mg one hour later. Also, half an hour after the procedure, patients in the intervention group will receive a third dose of medicine equivalent to half a milligram of colchicine to maintain the anti-inflammatory effect of colchicine until 24 hours after the procedure. Intervention 2: Control group: Patients in the placebo control group, which is exactly the same as colchicine in terms of color and size, will receive the first dose 12 to 24 hours before and the second dose one hour later. They will also receive the third dose half an hour after the procedure. Also, the level of troponin before and 24 hours after the procedure in this group will be measured in the same way as the intervention group with a troponin quantitative kit by the laboratory technician.It should be noted that the content of placebo is starch, which is without complications for patients. Yes - There is a plan to make this available What will be shared: Demographic information of patients without revealing their names, data from statistical analysis, information related to the main outcome of the study When: Up to one year after completing the study To whom: All members of society Conditions: After statistical analysis Where to obtain: Principal investigator How to obtain: Application through the Honorable Deputy of University Research and Deputy of Research of Shahid Madani Hospital Comments:
public Seyede Zohre Taheri
Lorestan University of Medical Sciences, Anoushirvan Rezaei Square
Khorramabad Iran (Islamic Republic of) 6813833946 +98 66 3322 9222 dr.taheri96@gmail.com Khoram-Abad University of Medical Sciences scientific Seyede Zohre Taheri
second floor, technical office, Lorestan University of Medical Sciences, Anoushirvan Rezaei Square
Khorramabad Iran (Islamic Republic of) 6813833946 +98 66 3322 9222 dr.taheri96@gmail.com Khoram-Abad University of Medical Sciences Iran (Islamic Republic of) Suffering from stable and unstable angina pectoris and myocardial infarction without ST segment elevation diagnosed by a cardiologist and a candidate for coronary angiography Not taking colchicine due to other diseases such as gout Not having a history of myelodysplasia Not taking corticosteroids or non-steroidal anti-inflammatory drugs except aspirin for 3 days before Absence of malignancy or active infection 18 years no limit Both Being allergic to colchicine Not being a candidate for angioplasty after angiography Glomerular filtration below 30 ml/min I25.11 Atherosclerotic heart disease of native coronary artery with angina pectoris Treatment - Drugs Placebo Intervention group: In the intervention group, patients will first receive 1 mg of colchicine (produced by Hashtgerd-Iran Mofid Pharmaceutical Company) 12 to 24 hours before the study and half a mg one hour later. Also, half an hour after the procedure, patients in the intervention group will receive a third dose of medicine equivalent to half a milligram of colchicine to maintain the anti-inflammatory effect of colchicine until 24 hours after the procedure. Control group: Patients in the placebo control group, which is exactly the same as colchicine in terms of color and size, will receive the first dose 12 to 24 hours before and the second dose one hour later. They will also receive the third dose half an hour after the procedure. Also, the level of troponin before and 24 hours after the procedure in this group will be measured in the same way as the intervention group with a troponin quantitative kit by the laboratory technician.It should be noted that the content of placebo is starch, which is without complications for patients. Troponin. Timepoint: Troponin measurement is done 12 to 24 hours before the angioplasty procedure and also 24 hours after the procedure. Method of measurement: The level of troponin will be measured 12 to 24 hours before the procedure, exactly before receiving the first dose of the drug or placebo, and also 24 hours after the procedure by the laboratory technician with the HUBI TNI troponin quantitative kit. Khoram-Abad University of Medical Sciences Approved 2023-10-15 Ethics Committee of Lorestan University of Medical Sciences Second floor, technical office, Lorestan University of Medical Sciences, Anoushirvan Rezaei Square, Khorramabad city Khorramabad Lorestan Iran (Islamic Republic of)