Substudy of the Leipzig Immediate Versus Early and Late Percutaneous Coronary Intervention Trial in NSTEMI - LIPSIA-NSTEMI TRIAL
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 602
- 试验地点
- 2
- 主要终点
- MACE
研究概览
简要总结
It is assumed that patients with non-ST-elevation myocardial infarctions (NSTEMI) showing an infero- or posterolateral occluded culprit artery (OCA) during diagnostic angiography frequently elude standard 12-lead electrocardiogram diagnosis. In addition, coronary collaterals may have beneficial effects in patients with OCA.
详细描述
We examined consecutive NSTEMI patients within 48 h of symptom onset. All patients underwent early invasive angiography plus optimal medical therapy. We compared baseline characteristics, procedural findings including analysis of TIMI-flow and collaterals using the Rentrop-classification, 30-day and 6-months major adverse cardiovascular events (MACE) in patients with and without totally OCA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •age between 18 and 90 years,
- •onset of angina pectoris at rest <24 h or crescendo angina in recent weeks with symptoms under minimal exertion or at rest lasting <24 h,
- •elevated troponin T ≥0.03 µg/L and
- •written informed consent.
排除标准
- •persistent angina,
- •ST-segment elevation myocardial infarction (STEMI),
- •hemodynamic instability including cardiogenic shock,
- •oral anticoagulation therapy,
- •contraindications for glycoprotein IIb/IIIa inhibitors,
- •other disease with life expectancy <6 months,
- •known coagulopathy,
- •pregnancy,
- •other suspected causes of troponin elevation as myocarditis, secondary to hypertensive crisis, or after cardiac decompensation,
- •no ability to consent, and
- •participation in another study.
结局指标
主要结局
MACE
时间窗: 6 months
composite of death, reinfarction and readmission for unstable angina within 6 months after inclusion
次要结局
- CK and CK-MB(48 hours)