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临床试验/NCT01725373
NCT01725373已完成不适用

Prospective Registry in Patients With Unprotected Left Main Disease Treated by Percutaneous Coronary Intervention: The ALMA (Angioplasty of Left Main - lAriboisiere) Registry

Hopital Lariboisière1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2007年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
125
试验地点
1
主要终点
Major cardiovascular events (MACCE)

研究概览

简要总结

In patients with unprotected left main disease (ULMD), angioplasty is emerging as an alternative technique. The investigators aimed to determine the rate of major cardiovascular events in patients treated by angioplasty for ULMD in a "real world" registry.

详细描述

Current guidelines recommend coronary artery bypass graft surgery as the "gold standard" treatment in patients with unprotected left main disease. However, patients with ULMD and high surgical risk score or favourable anatomy are still referred for angioplasty. Recently, several studies and registries comparing surgery and percutaneous intervention with drug eluting stents report similar results regarding cardiovascular death and myocardial infarction in patients with multivessel coronary artery disease including unprotected left main disease.

The aim of the study is to evaluate major cardiovascular events in a "real world" registry.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • stable or unstable angina and/or documented ischemia
  • 50% de novo ULMD referred for angioplasty

排除标准

  • acute coronary syndrome with ST elevation,
  • cardiogenic shock or out of hospital cardiac arrest

结局指标

主要结局

Major cardiovascular events (MACCE)

时间窗: One year

Major cardiovascular events (MACCE)were measured after 1 year follow-up. MACCE included all-cause of death, stroke, myocardial infarction, and repeat revascularizations. Non-Q-wave myocardial infarction was defined using universal definition with troponin I. Stent thrombosis was defined according to the Academic Research Consortium definition as definite, probable, or possible and as early or late after the index procedure. Repeat revascularization was composed of any repeat percutaneous intervention or surgical bypass.

次要结局

未报告次要终点

研究者

发起方
Hopital Lariboisière
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Jean-Guillaume DILLINGER

Principal investigator - Medical Doctor in the Departement of Cardiology

Hopital Lariboisière

研究点 (1)

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Angioplasty of Left Main - lAriboisiere Registry | 临床试验