Post-MI PET Scan Imaging of Inflammation
- Registration Number
- NCT02281305
- Lead Sponsor
- G.Gennimatas General Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Colchicine Active treatment group Colchicine Drug: Colchicine 2 mg loading dose; 0.5 mg bid for 5 days
- Primary Outcome Measures
Name Time Method Degree of inflammation of the involved myocardium as assessed by the PET scan 5 days post-MI
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Athens General Hospital "G. Gennimatas"
🇬🇷Athens, Attika, Greece