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临床试验/NCT01818960
NCT01818960Unknown不适用

Revascularization Strategies for ST Elevation Myocardial Infarction; The Cardiac Magnetic Resonance Endpoint Study

Unity Health Toronto6 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2014年4月最近更新:
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

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

申办方类型
Other
责任方
Sponsor

研究点 (6)

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