Post-MI PET Scan Imaging of Inflammation

Study Overview
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Brief Summary
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Restoring the patency of the coronary vessels and providing the ischemic myocardium with reperfused blood can cause additional tissue damage. A key element of ischemia and reperfusion (I/R) injury and major determinant of the evolution of damage in the affected myocardium is the inflammatory response. The main objective of the study is to evaluate the efficacy of colchicine in reducing I/R injury by effectively modulating the inflammatory response in the reperfused myocardium.

Official Title
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Imaging of Inflammation in the Postischemic Myocardium: Effect of Anti-inflammatory Treatment With Colchicine

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Drug: Colchicine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The study will enroll patients 18 years old or older Who presented to the hospital within twelve (12) hours of the onset of chest pain -Who had ST segment elevation > 1 mm in two contiguous limb leads or ST segment elevation > 2 mm in two consecutive precordial leads or new onset of left bundle branch block (LBBB) in a twelve lead electrocardiogram and for whom the decision was made to be taken to the cath lab to perform angioplasty of the coronary vessels. Exclusion Criteria: Excluded patients: with age > 80 years old with active inflammatory diseases, infectious diseases or known malignancy under treatment with corticosteroids, anti-inflammatory agents or disease modifying agents with known hypersensitivity-allergy to colchicine under chronic treatment with colchicine with severe renal failure (eGFR < 30 ml/min/1.73 m2) with hepatic failure (Child - Pugh class B or C) presented with cardiac arrest presented with ventricular fibrillation presented with cardiogenic shock with stent thrombosis with angina within 48 hours before infarction with previous myocardial infarction in the affected territory with occlusion of the left main or left circumflex coronary or the right coronary artery or with evidence of coronary collaterals to the region at risk on initial coronary angiography (at the time of admission)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colchicine Active treatment group<br>Drug: Colchicine 2 mg loading dose; 0.5 mg bid for 5 days | Drug: Colchicine<br> <br> |
| Placebo Comparator: Control group<br>Drug: Placebo | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of inflammation of the involved myocardium as assessed by the PET scan |  | 5 days post-MI |