Randomized Study of ImmeDiate Versus DeLayEd Invasive Intervention in Patients With Non ST-segment Elevation Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 323
- 试验地点
- 2
- 主要终点
- Composite of all-cause death or myocardial reinfarction
研究概览
简要总结
In patients with acute myocardial infarction without ST-segment elevation on ECG (non-STEMI), previous studies have indicated that routine invasive treatment confers more benefit as compared to selective invasive approach. The benefits of routine invasive coronary intervention have been the most evident in patients with higher baseline risk profile. However, the question of optimal timing of routine invasive intervention remains unsolved.
Immediate invasive intervention early after admission for non-STEMI may limit myocardial necrosis by securing the patency of the culprit coronary artery. Nevertheless, several previous studies reported higher levels of biomarkers of myocardial injury in patients undergoing early PCI. The question of earlier versus delayed procedure in non-STEMI patients may thus amount to whether the risk of intervening on an unstable plaque is greater than the risk of new ischemic events while waiting for the invasive procedure.
The purpose of the present study is to compare effects of immediate coronary intervention, within 2 hours of admission, versus delayed intervention, within 2-72 hours after admission, in patients witn non-STEMI.
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
- Single (Outcomes Assessor)
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
- •episode of chest pain occurring no longer than 24 hours prior to admission
- •elevation of cardiac troponin I above the upper limit of normal (ULN)
- •new ST-segment depression at least 1 millivolt (mV) and/or T-wave inversion or transient ST-segment elevation in ≥ 2 contiguous leads
排除标准
- •age < 18 years
- •persistent ST-segment elevation
- •hemodynamic instability
- •cardiogenic shock on admission
- •life-threatening ventricular arrhythmias on admission
- •refractory angina on admission
- •active bleeding
- •any contraindication for the use of dual antiplatelet therapy (DAPT)
- •presence of comorbidities with life expectancy < 6 months
结局指标
主要结局
Composite of all-cause death or myocardial reinfarction
时间窗: within 30 days of randomization
次要结局
- Composite of all-cause death, myocardial reinfarction or recurrent ischemia(within 30 days of randomization)
- All-cause mortality(within 30 days, 1, 3 and 5 years after randomization)
- Myocardial reinfarction(within 30 days, 1, 3 and 5 years after randomization)
- Stroke(within 30 days, 1, 3 and 5 years after randomization)
- Major bleeding(within 30 days, 1, 3 and 5 years after randomization)
- Duration of index hospitalization(at 30-day follow-up, the duration of hospital stay is assessed)
- Recurrent ischemia(within 30 days of randomization)
研究者
Aleksandra Milosevic
MD
Clinical Centre of Serbia