Multivessel Coronary Disease Diagnosed at the Time of Primary PCI for STEMI: Complete Revascularization Versus Conservative Strategy. PRAGUE - 13 Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 213
- 试验地点
- 2
- 主要终点
- composite endpoint of death, nonfatal acute myocardial infarction and stroke
研究概览
简要总结
The aim of the study is to find the optimal management of patients with acute myocardial infarction with ST elevations treated by primary PCI who have at least one significant stenosis of non-culprit coronary artery. The primary endpoint of the study will be incidence of combined endpoint of all cause mortality, nonfatal myocardial infarction and stroke during the follow up of 24 months in group of patients treated with staged revascularization (PCI or CABG) in comparison with patients treated conservatively.
详细描述
Introduction:
Primary percutaneous coronary intervention (PPCI) of the occlussion or significant stenosis of infarct artery is a method of choice in treatment of acute myocardial infarction with ST segment elevation (STEMI). It is not clear, what is the optimal management of patients with acute myocardial infarction with ST elevations (STEMI) treated by primary percutaneous coronary intervention (PPCI) who have at least one significant stenosis of non-culprit coronary artery. Numerous cardiology centers perform staged PCI on significant stenoses involving the "non-infarct" coronary artery (arteries) 3-40 days after PPCI, but the benefit of this staged PCI for such patients has not yet been clearly demonstrated.
Aim of study:
The aim is to find the optimal management of patients with acute myocardial infarction with ST elevations (STEMI) treated by PPCI who have at least one significant stenosis of non-culprit coronary artery. The primary endpoint of the study will be incidence of combined endpoint of all cause mortality, nonfatal myocardial infarction and stroke during the follow up of 24 months in group of patients treated with staged revascularization (PCI or CABG) in comparison with patients treated conservatively.
Hypothesis:
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
- •Patient with acute myocardial infarction with ST segment elevation (STEMI)
- •Angiographically successful primary PCI of infarct-related stenosis (TIMI flow grades II-III)
- •One or more other stenoses (≥70%) of "non-infarct" coronary artery (arteries) found by coronary angiography, (diameter of artery ≥ 2,5mm)
- •Enrollment ≥48 hours following onset of symptoms
排除标准
- •Stenosis of the left main of left coronary artery ≥ 50%
- •Hemodynamically significant valvular disease
- •Patients in cardiogenic shock during STEMI
- •Hemodynamic instability
- •Angina pectoris > grade 2 CCS lasting 1 month prior to STEMI
结局指标
主要结局
composite endpoint of death, nonfatal acute myocardial infarction and stroke
时间窗: 2 years
次要结局
- changes of left ventricular ejection fraction(2 years)
- target lesion revascularization(2 years)
- recurrent myocardial infarction(2 years)
- hospitalization for heart failure(2 years)
- hospitalization for unstable angina pectoris(2 years)
- target vessel revascularization(2 years)
- target vessel failure(2 years)
- cardiovascular death(2 years)
- stroke(2 years)
- outcomes of questionnaire regarding angina pectoris(2 years)
研究者
Ota Hlinomaz, MD, PhD
Ota Hlinomaz, MD, PhD
St. Anne's University Hospital Brno, Czech Republic