NCT01818960Unknown不适用
Revascularization Strategies for ST Elevation Myocardial Infarction; The Cardiac Magnetic Resonance Endpoint Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 6
- 主要终点
- Infarct size by CMR
研究概览
简要总结
Revascularization strategies for ST elevation myocardial infarction (STEMI) study (ASSIST-CMR) will compare the effects of two revascularization strategies [same sitting multivessel primary PCI (SS-PCI) and culprit vessel only primary PCI (IRA-PCI)] on myocardial infarct size (MIS) as determined by cardiac magnetic resonance (CMR) imaging in patients presenting with STEMI and multivessel disease (MVD).
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
- •High risk ST elevation myocardial infarction evidenced by: ≥2 mm ST elevation in 2 anterior or lateral leads; or ≥2 mm ST elevation in 2 inferior coupled with ST depression in 2 contiguous anterior leads for a total ST deviation of ≥8 mm; or New left bundle branch block with at least 1 mm concordant ST elevation.
- •Multivessel CAD as evidenced by ≥1 significant (≥70% by visual assessment or FFR<0.80 for 50-70% stenosis) stenosis in non-IRA.
- •Successful IRA-PCI with <10% residual angiographic stenosis and TIMI III flow.
- •Written informed consent.
排除标准
- •Age ≤ 18 years.
- •Prior coronary artery bypass graft (CABG) surgery.
- •Administration of thrombolytic therapy.
- •Non-IRA stenosis is a chronic total occlusion or located in left main artery.
- •Hemodynamic instability evidenced by BP<90 mmHg, Killip class ≥2, need for inotropes/vasopressors.
- •Known renal insufficiency (estimated GFR < 50ml/min).
- •Contraindication to CMR.
结局指标
主要结局
Infarct size by CMR
时间窗: 90 days
次要结局
- MACE rate(One year)
研究者
研究点 (6)
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