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临床试验/NCT01179126
NCT01179126Unknown3 期

Complete Revascularization Or streSS Echo in Patients With Multivessel Disease and ST-segment Elevation Acute Myocardial Infarction

Complexo Hospitalario Universitario de A Coruña2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2010年9月1日最近更新:
适应症

试验速览

阶段
3 期
发起方
入组人数
400
试验地点
2
主要终点
Combined event of cardiovascular death/re-myocardial infarction/revascularization of any vessel/admission due to heart failure

研究概览

简要总结

Multivessel disease has been reported to occur between 40 and 60% of patients with ST-segment elevation myocardial infarction (STEMI) and has been associated to a worse prognosis. Multivessel revascularization offers a myriad of potential advantages as enhance of the collateral blood flow, greater myocardial salvage, the stabilization of other lesions that can be potentially vulnerable, and the achievement of a complete revascularization, factor that is associated with a better prognosis. On the other hand, the prolongation of procedural duration, the hazard of contrast induced nephropathy and the peri-procedural complications can limit the widespread of this practice.

To date, very few observational studies have focused in the multivessel revascularization with disparity of results. Whereas ones have observed an increase of adverse cardiovascular events and thus not recommend it, others have shown neutral results.

Stress echocardiography has been shown to be an adequate technique for the diagnosis of coronary artery disease and could be an appropriate tool for selecting the lesions that need to be revascularized because they induce large areas of ischemia. However, this technique has also limitations like the high operator-dependence.

Therefore, the investigators sought to study if the complete multivessel revascularization of patients with STEMI treated by means of primary percutaneous coronary intervention (PCI) has an impact on prognosis compared to a strategy of treating only those non-culprit lesions that produce large areas of ischemia in a stress test.

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

  • Typical chest pain lasting >30 minutes with ST-segment elevation >=1mm in >=2 contiguous ECG leads or left bundle branch block and presentation < 48 hours since symptom onset.
  • Patients undergoing rescue PCI
  • Patients with effective lysis and coronary angiography in less than 24 hours
  • Presence of other lesion >=70% in a non-culprit artery.
  • Informed consent

排除标准

  • Significant left main disease
  • Lesions in vessels < 2 mm
  • Lesions in branches of a main epicardial coronary artery and short irrigation territory
  • Previous coronary artery bypass graft (CABG)
  • Any coronary intervention in the previous month
  • Cardiogenic shock
  • Anatomic features no suitable for coronary intervention
  • Pregnancy

结局指标

主要结局

Combined event of cardiovascular death/re-myocardial infarction/revascularization of any vessel/admission due to heart failure

时间窗: one year

次要结局

  • Incidence of acute renal failure (contrast induced nephropathy)(Admission)
  • Cost analysis of both strategies(1 year)
  • Death(one year)
  • re-myocardial infarction(one year)
  • revascularization of any vessel(one year)
  • admission due to heart failure(one year)

研究者

发起方
Complexo Hospitalario Universitario de A Coruña
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rodrigo Estévez-Loureiro

MD, PhD

Complexo Hospitalario Universitario de A Coruña

研究点 (2)

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