Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT05745818
Brief Summary:
Study of role of colchicine in reducing periprocedural myocardial injury in patients prepared for elective PCI and its role in reduction of MACEs.
Detailed Description:
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.
Study:
NCT05745818
Study Brief:
Protocol Section:
NCT05745818