COlchicine for Left VEntricular Remodeling Treatment in Acute Myocardial Infarction
Status:
Recruiting
Trial end date:
2022-01-01
Target enrollment:
Participant gender:
Summary
Inflammatory processes have been identified as key mediators of ischemia/ reperfusion injury
in ST-segment elevation myocardial infarction. They add additional damage to the myocardium
and are associated with clinical adverse events (heart failure and cardiovascular death) and
poor myocardial recovery. All the different anti-inflammatory approaches to reduce
reperfusion injury have been disappointing.
Colchicine is a well-known substance with potent anti-inflammatory properties. In a recent
pilot study performed in 151 acute STEMI patients treated with primary percutaneous coronary
intervention(PPCI) Deftereos et al. showed a 50% reduction of infarct size (creatine kinase
release) with a short course treatment of colchicine in comparison to placebo.
One mechanism to explain this effect could be the reduction of adverse left ventricular (LV)
remodelling. LV remodelling is part of the healing process of myocardium after MI. It is
defined as the end diastolic volume (EDV) increase in the first months after MI. Adverse LV
remodelling is increased by inflammation and ultimately leads to heart failure.
Our main hypothesis is that colchicine with its anti-inflammatory properties significantly
reduces the initiation of adverse LV remodelling, together with a significant reduction of
infarct size and microvascular obstruction in comparison to placebo in acute STEMI patients
referred for PPCI.
After inclusion and randomisation, patients will receive the first part of their experimental
treatment: colchicine or placebo before PCI, then, the second part after PCI and during 5
days. They will be followed up during their hospitalization and until one year. In order to
evaluate LV remodelling, two cardiac magnetic resonance studies will be performed during
their participation: one during their hospitalization and a second at 3 months. At 1 year,
adverse events will be collected by phone.