COLchicine to Prevent Sympathetic Denervation After an Acute Myocardial Infarction

Phase 3TerminatedNCT04420624

University Hospital, Montpellier54 enrolled

Overview

This study evaluates the benefit of colchicine on induced denervation after myocardial infarction. Patients who have suffered a documented De Novo myocardial infarction and completed a revascularization procedure will receive either colchicine on top of standard therapy, compared to standard therapy alone (1:1 allocation ratio). Colchicine 1mg (or 0.5mg) will be initiated within 48h after percutaneous revascularization and prescribed for one month.

COLD-MI study aims to explore colchicine's impact on myocardial denervation following reperfused acute myocardial infarction. Acute myocardial infarction is the leading cause of heart failure (HF). It induces myocardial denervation predisposing to ventricular rhythm disorders and death. This denervation linked to infarction's size occurs by direct ischaemic mechanisms during the initial coronary occlusion (initially non-vascularised zone) and secondarily by cardiac remodelling in the context of the heart failure (HF). In usual practice, cardiac denervation which intensity is correlated with rhythm and mortality risks, can be evaluated by scintigraphy. In a murine reperfusion model of ischemia, the direct anti-inflammatory effect of colchicine reduces the size of the necrosis and improves post-ischemic remodeling. This suggests that colchicine may reduce myocardial denervation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Myocardial Infarction, Acute

Interventions

ColchicineDRUG

1 mg (or 0.5mg) tablet of colchicine taken once a day for 1 month

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age from 18 to 80 year old * Hospitalization within 12 hours of onset of acute chest pain * Patient must have suffered a documented acute myocardial infarction * Coronary occlusion on initial angiography (culprit artery with aTIMI (Thrombolysis in Myocardial Infarction) flow 1 or 0) * Patient eligible for a revascularization procedure by PTCA (Percutaneous transluminal coronary angioplasty) Exclusion Criteria: * Patients with a history of myocardial infarction prior to the current episode * Patient in cardiogenic shock or with hemodynamic instability * Patients with severe hepatic or renal dysfunction (GFR ≤30 mL/min) * Pregnant women or women of childbearing age without contraception * Treatment with a potent CYP3A4 inhibitor or a P-glycoprotein inhibitor in patients with renal or hepatic impairement * Association with macrolides (except spiramycin) * Association with pristinamycin

Locations (1)

UH Montpellier

Montpellier, France

Outcomes

Primary Outcomes

Percentage of myocardial denervation

assess by MIBG (méta-iodobenzylguanidine)-nuclear cardiac imaging

Time frame: 6 month

Secondary Outcomes

Change in the heart-to-mediastinum ratio

The heart-to-mediastinum (H/M) ratio, the heart count normalized for the mediastinum count, is used as a quantitative index in cardiac 123 I-MIBG imaging.

Time frame: 6 month

Left Ventricular Ejection Fraction in percent

By transthoracic echocardiogram (TTE)

Time frame: 6 month

Left Ventricular Ejection Fraction in percent

By MIBG (méta-iodobenzylguanidine)-nuclear cardiac imaging

Time frame: 6 month

Left Ventricular Ejection Fraction in percent

By transthoracic echocardiogram (TTE)

Time frame: 1 month

Change in Sinus variability

by 24 hours holter recording : SDNN (Standard Deviation of NN intervals) will be measured

Time frame: 6 month

Change in Sinus variability

by 24 hours holter recording : SDNN (Standard Deviation of NN intervals) will be measured

Time frame: 1 month

Basic ECG parameters (QRS duration)

Time frame: 6 month

Basic ECG parameters (QRS duration)

Data from ClinicalTrials.gov

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