COMBinAtion Therapy in Myocardial Infarction: The COMBAT-MI Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 378
- 试验地点
- 6
- 主要终点
- Myocardial Infarct Size
研究概览
简要总结
Remote ischemic conditioning (RIC) and intravenous exenatide administered immediately before primary angioplasty have been found to limit infarct size in patients with STEMI (ST segment elevation myocardial infarction), but the reduction is limited. This study investigates whether a combination therapy including both therapies is more effective.
详细描述
COMBAT-MI is an investigator-driven, randomized, double-blind and placebo-controlled clinical trial aimed at evaluating the effect of Remote Ischemic Conditioning and exenatide, alone and in combination, on Myocardial Infarct size in 428 STEMI patients (107 per group) (ST segment elevation myocardial infarction). Patients with TIMI (Thrombolysis in Myocardial Infarction) flow grade > 1 will be excluded. The study has a 2 x 2 factorial design (Remote Ischemic Conditioning , Exenatide, both or neither). The primary end-point will be Myocardial Infarct size measured by Cardiac Magnetic Resonance Imaging (CMRI) performed 3 - 7 days after primary Percutaneous Coronary Intervention (pPCI) (expressed as % of left ventricular (LV) mass). Sample size has been calculated in 274 patients with TIMI 0-1 available for analysis of the primary end-point, and inclusion will end when this number is reached, which will require, according to the current rate of TIMI 0-1 in our STEMI population, to randomize 428 patients. Secondary end-points will include myocardial salvage index, based on angiographic and CMRI derived estimations of the area at risk, and frequency of Major Adverse Cardiovascular Events (MACE) and of major adverse events during admission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women ≥18 years of age
- •STEMI characterized by 2 mm ST segment elevation in 2 or more V1 through V4 leads or presumed new left bundle branch block with minimum of 1 mm concordant ST elevation or 1 mV(millivolt) ST segment elevation in the limb leads (II, III and aVF leads, I, aVL leads) and V4-V
- •Patients presenting within 6 hours of chest pain.
排除标准
- •Known hypersensitivity to exenatide or any of the excipients
- •Known contraindication to CMR imaging such as significant claustrophobia, severe allergy to gadolinium chelate contrast, severe renal insufficiency (defined as estimated glomerular filtration rate [eGFR] (epidermal growth factor receptor) <30 mL/min/1.73 m2), presence of CMRI contraindicated implanted devices (e.g., pacemaker, implanted cardiac defibrillator, cardiac resynchronization therapy device, cochlear implant), embedded metal objects (e.g., shrapnel), or any other contraindication for CMRI.
- •Assumed life expectancy < 1 year e.g. due to non-cardiac disease.
- •TIMI flow grade > 1 at the time of diagnostic coronary angiography. These patients will be excluded from the analysis of infarct size but will be included in the safety analysis.
- •Pregnant women
- •Patients with loss of consciousness or confused, not able to read the information and to sign the writting consent
- •Patients with oro-tracheal intubation
- •Patients with cardiogenic shock persisting 48h after reperfusion
研究组 & 干预措施
Remote Ischemic Conditioning
Remote Ischemic Conditioning + placebo
干预措施: Remote Ischemic Conditioning (RIC) (Other)
Remote Ischemic Conditioning
Remote Ischemic Conditioning + placebo
干预措施: Placebo (Drug)
Combined treatment
Remote Ischemic Conditioning + exenatide
干预措施: Exenatide (Drug)
Combined treatment
Remote Ischemic Conditioning + exenatide
干预措施: Remote Ischemic Conditioning (RIC) (Other)
Placebo
Sham Remote Ischemic Conditioning + placebo
干预措施: Remote Ischemic Conditioning (RIC) (Other)
Placebo
Sham Remote Ischemic Conditioning + placebo
干预措施: Placebo (Drug)
Exenatide
Sham Remote Ischemic Conditioning + exenatide
干预措施: Exenatide (Drug)
Exenatide
Sham Remote Ischemic Conditioning + exenatide
干预措施: Remote Ischemic Conditioning (RIC) (Other)
结局指标
主要结局
Myocardial Infarct Size
时间窗: 3-7 days after pPCI
MI, measured by late gadolinium enhancement in CMRI 3-7 days after pPCI, and expressed as percent of left ventricular mass.
次要结局
- Transmurality index(3-7 days after pPCI)
- Ventricular volumes(3-7 days after pPCI)
- Microvascular obstruction(3-7 days after pPCI)
- Markers of successful reperfusion(First 90 min after reperfusion)
- Myocardial salvage index(3-7 days after pPCI)
- Major adverse cardiac events (MACE)(Hospital discharge and expected average of 1 week, one year follow-up)