COLchicine to Prevent Sympathetic Denervation After an Acute Myocardial Infarction
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Percentage of myocardial denervation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Colchicine
colchicine and standard therapy
干预措施: Colchicine (Drug)
结局指标
主要结局
Percentage of myocardial denervation
时间窗: 6 month
assess by MIBG (méta-iodobenzylguanidine)-nuclear cardiac imaging
次要结局
- Change in Sinus variability(1 month)
- Time from randomization to heart failure hospitalization(6 month)
- Time from randomization to all-cause hospitalization(6 month)
- Change in the heart-to-mediastinum ratio(6 month)
- Basic ECG parameters (corrected QT)(6 month)
- Time from randomization to death (total mortality)(6 month)
- Left Ventricular Ejection Fraction in percent(1 month)
- Biological evaluation of infarction size Creatine PhosphoKinase (CPK)(During hospitalization (Day 1 to Day 5))
- Biological evaluation of infarction size (troponin)(During hospitalization (Day 1 to Day 5))
- Basic ECG parameters (QRS duration)(1 month)
- Number of ventricular extrasystole (2 or 3 VES) per 24 hours on the Holter(6 month)
- Number of ventricular or supraventricular tachycardia (>3 VES) episodes per 24 hours(6 month)
- Number of bursts (2 or 3 VES) per 24 hours on the Holter(6 month)
- Infarct size in percentage of left ventricular(6 month)
- Number of Adverse event(from randomization to 6 months)
- Variations in the levels of neurotrophic molecular markers(Between 1 month and 6 months)
- Post infarction systemic inflammation evaluation(Between 1 month and 6 months)