MINI-AMI: Minimizing INfarct Size With IMPELLA® 2.5 System Following PCI for Acute Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Abiomed Inc.
- 入组人数
- 5
- 主要终点
- Infarct Size
研究概览
简要总结
A prospective, randomized, controlled multi-site feasibility trial to assess the potential role of the IMPELLA® 2.5 System in reducing infarct size in patients with ST-elevation myocardial infarction (STEMI)
详细描述
The primary objective of this study is to evaluate whether the adjunctive use of the IMPELLA® 2.5 System for 24 hours following primary PCI for STEMI has the potential to limit the infarction of at-risk myocardium compared to primary PCI with routine post-PCI care (standard of care). This study is a feasibility study. Therefore, the principal objective is to identify trends in cardiac magnetic resonance imaging (MRI)-based efficacy outcomes between the randomized treatment arms (Impella arm compared standard of care.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Signed Informed Consent
- •Acute anterior STEMI with ≥2 mm of ST-segment elevation in 2 or more contiguous anterior leads or ≥ 4 mm in total in the anterior leads, OR, Large Inferior STEMI with ≥2 mm of ST-segment elevation in 2 or more inferior leads AND EITHER ≥1 mm ST-segment elevation in V1 OR ≥1 mm of ST-segment depression in ≥2 contiguous anterior leads (V1-V3)
- •Primary PCI performed within 5 hours of the onset of symptoms
- •Patient undergoing emergent primary PCI of one culprit lesion in one major native epicardial coronary vessel
- •Successful revascularization of the culprit native coronary artery with TIMI Flow Grade of 3 at the end of PCI
排除标准
- •Cardiac arrest requiring CPR within 24 hours prior to enrollment
- •Current cardiogenic shock
- •Left Bundle Branch Block (new or old)
- •Atrial fibrillation
- •Known history of prior MI
- •Prior coronary artery bypass graft surgery
- •Known mural thrombus in the left ventricle or contraindication to left ventriculography
- •Presence of a mechanical aortic valve
- •Documented presence of moderate to severe aortic stenosis or moderate to severe aortic insufficiency.
- •Known history of severe kidney dysfunction.
- •Known contraindication to MRI (implanted metallic or magnetically activated device; claustrophobia, inability to hold breath for 15 seconds).
- •History of recent (within 1 month) stroke or TIA
- •History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
- •Administration of fibrinolytic therapy within 24 hours
- •Known hypersensitivity or contraindication to any of the following: Heparin, pork or pork products; Aspirin, All of the following: Clopidogrel, Ticlopidine, Prasugrel
- •Contrast media Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device.
- •Severe peripheral arterial obstructive disease that would preclude the IMPELLA® System placement
- •Requirement to treat two or more culprit vessels during primary PCI, or plan for staged coronary revascularization (PCI or CABG) within the next 30 days.
- •Inability to place Impella within 6 hours of the onset of symptoms, should patient be randomized to this arm.
研究组 & 干预措施
Standard of care
Patients in the control arm will be treated with standard of care for post-PCI STEMI patients in accordance with the the 2004 ACC/AHA Guidelines for the Management of Patients with ST-elevation Myocardial Infarction.
干预措施: Standard of care (Control) (Other)
Impella 2.5
24 hours of support with the Impella 2.5 post-PCI for acute myocardial infarction.
干预措施: Impella 2.5 support (Device)
结局指标
主要结局
Infarct Size
时间窗: 3-5 Days post infarct
Infarct size (as assessed by cardiac MRI at 3-5 days following the infarction).
No Data for Primary or Secondary Enpoints Were Collected
时间窗: No data for primary or secondary enpoints were collected
次要结局
- Infarct Size(90 Days)