Periprocedural Myocardial Infarction Clinical Trial
Official title:
Colchicine for Reduction of Periprocedural Myocardial Injury in Percutaneous Coronary Intervention
Study of role of colchicine in reducing periprocedural myocardial injury in patients prepared for elective PCI and its role in reduction of MACEs.
Prospective open-label randomized cohort study including two groups of patients admitted and prepared for elective PCI at cardiology unit, IMD, Sohag University Hospital, these two groups are: 1. group of patients received oral tablet colchicine 6-24 hours before PCI loading dose 1 mg followed by 500 mcg after one hour. N.B. usual side effects of colchicine gastrointestinal disorders rarely, myalgia and weakness. Treatment of side effects symptomatic treatment ( antiemetic, etc.) 2. control group of patients. Number of patients according to sample size equation. Sample size equation is used to calculate the minimum size of the required sample: n = (z)2 p (1- p) / d2 - Number of patients according to sample size equation about 300 patients 150 patient in each group of study. - Estimated study duration 2 years. - N.B. Randomization method: first patient prepared to PCI will be included in colchicine group second patient will be included in control group and so on. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04239404 -
Prognostic Impact of PMI in Stable CAD Undergoing PCI
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