Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction to Reduce Infarct Size (DTU): A Prospective Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abiomed Inc.
- 入组人数
- 50
- 试验地点
- 30
- 主要终点
- Infarct size at 30 Days
研究概览
简要总结
Direct active unloading of the left ventricle with the Impella CP System prior to PPCI in patients with ST-elevation myocardial infarction (STEMI) is safe and feasible
详细描述
A multi-center, prospective, randomized, two-arm feasibility trial to assess the potential role of unloading with the Impella CP prior to revascularization in reducing infarct size. The study design includes 1:1 randomization between: 1) Delay Arm: 30 minutes of unloading with Impella CP prior to primary percutaneous coronary intervention (PPCI); and 2) Immediate Arm: initiation of Impella CP unloading followed immediately by PPCI.
Study Hypothesis: Direct active unloading of the left ventricle with the Impella CP System prior to PPCI in patients with ST-elevation myocardial infarction (STEMI) is safe and feasible
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
- None
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21-80 years
- •First myocardial infarction
- •Acute anterior STEMI with ≥ 2 mm in 2 or more contiguous anterior leads or≥ 4 mm total ST-segment deviation sum in the anterior leads
- •Signed Informed Consent
排除标准
- •Cardiogenic shock defined as: systemic hypotension (systolic BP less than 90 mmHg or the need for inotropes/pressors to maintain a systolic BP Greater than 90mmHg) plus one of the following: any requirement for pressors/inotropes prior to arrival at the cath lab, clinical evidence of end organ hypoperfusion, lactate level greater than 2.5mmol/L
- •Inferior STEMI or suspected right ventricular failure
- •Suspected or known pregnancy
- •Suspected active infection
- •History or known hepatic insufficiency prior to catheterization
- •On dialysis therapy
- •Known contraindication to:
- •Undergoing MRI or use of gadolinium
- •Heparin, pork, pork products or contrast media
- •Receiving a drug-eluting stent
- •Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device
研究组 & 干预措施
Prolonged unloading prior to PPCI
Activation of Impella CP for a 30 minute duration prior to primary percutaneous coronary intervention
干预措施: Impella unloading prior to PPCI (Device)
Immediate unloading prior to PPCI
Activation of Impella CP immediately prior to primary percutaneous coronary intervention
干预措施: Impella unloading prior to PPCI (Device)
结局指标
主要结局
Infarct size at 30 Days
时间窗: 30 Days
Assessment of infarct size as percent of left ventricular (LV) mass, evaluated using CMR, at 30 days post-PPCI
MACCE at 30 Days
时间窗: 30 Days
A composite of the following Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) at 30 days: * Cardiovascular mortality * Re-infarction * Stroke/TIA * Major vascular complication
次要结局
- Infarct Characteristics - LV mass(3 - 5 and 30 Days)
- 30 Day Safety Endpoint Rates(30 Days)
- Infarct Characteristics microvascular obstruction(3-5 and 30 Days)
- Left Ventricular Function- LV end systolic and diastolic volume index(3-5 and 30 Days)
- Infarct Characteristics - area at risk(3 - 5 and 30 Days)
- Left Ventricular Function - Ejection Fraction(3-5 and 30 Days)