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.

Inclusion Criteria:

1. Elective PCI in ACS patients with cardiac troponin peaked and stabilized and CCS patients .
2. PP Myocardial Injury (Any increase in post-PCI troponin if pre-PCI troponin is negative or rise in post-PCI troponin above baseline pre-PCI troponin when it is peaked and stabilized).
3. PPMI (rise in post-PCI troponin plus new evidence of ischemia).

Exclusion Criteria:

1. Patients with active infections.
2. Patients taking anti-inflammatory medications.
3. Patients presented with ACS( still rising troponin).
4. Severe renal impairment ( creatinine clearance < 45 ml/min ).
5. Primary PCI, rescue PCI, pharmacoinvasive therapy.
6. Connective tissue diseases.

IHD patients in IMD sohag university hospital prepared for elective PCI