ImmeDiate Versus EArLy Invasive Approach in Non-ST-Elevation Myocardial Infarction (IDEAL NSTEMI)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Death and non-fatal recurrent infarction
研究概览
简要总结
Of estimated 140,000 cases of acute myocardial infarction admitted to hospitals in Germany per year, approximately 50% present with Non-ST-elevation myocardial infarction (NSTEMI). The currently available evidence led to current guideline recommendations that a systematic approach of immediate angiography in NSTEMI patients stabilized with contemporary antiplatelet treatment is not mandatory. However, this immediate invasive approach is appealing because it allows treating the underlying cause (the plaque rupture) as early as possible with subsequent reduction of death and recurrent myocardial infarction. In the IDEAL NSTEMI trial we test an immediate invasive approach (<2 h) with an approach 12-72 h according top guidelines with respect to 6 months death and mortality.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NSTEMI with
- •ischemic symptoms >10 minutes within 24 h
- •elevated troponin or creatine kinase above the upper limit of normal
- •ST-segment depression or transient ST-segment elevation, T-wave inversion
- •informed consent.
排除标准
- •Age < 18 years
- •Age > 90 years
- •persistent angina
- •hemodynamic instability
- •overt congestive heart failure
- •life-threatening arrhythmias
- •limited life-expectancy < 6 months
- •chronic oral anticoagulation
- •fibrinolysis < 48 hours
- •PCI < 14 days
- •contraindication for treatment with glycoprotein IIb/IIIa inhibitors, heparin, aspirin and clopidogrel
- •recent major trauma or surgery
研究组 & 干预措施
immediate angiography
Immediate invasive angiography < 2 h after randomization
干预措施: immediate angiography and revascularization (Procedure)
early invasive angiography
early invasive angiography 12-72 h after randomization
干预措施: early invasive angiography (Procedure)
结局指标
主要结局
Death and non-fatal recurrent infarction
时间窗: 6 months
次要结局
- Composite of death, recurrent non-fatal myocardial infarction, refractory ischemia or target vessel re-vascularization(6 months)
研究者
Holger Thiele
Clinical Professor Prof. Dr. Holger Thiele
University of Leipzig