跳至主要内容
临床试验/NCT01593865
NCT01593865Unknown不适用

Observational, Case-Control, Propensity-Matched Study of Bilateral Versus Monolateral Internal Mammary Artery Grafting for Severe Coronary Artery Disease. Assessment of Feasibility of Systematic Bilateral Mammary Artery Grafting and Early/Late Clinical Outcomes

Catholic University, Italy1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,000
试验地点
1
主要终点
Feasibility of systematic BIMA grafting

研究概览

简要总结

The present study hypothesizes that the systematic use of bilateral internal mammary artery (BIMA) grafting is feasible in the practice of a University Cardiac Surgery Institution for the treatment of multivessel coronary artery disease (primary hypothesis). The secondary study hypothesis is that the BIMA grafting meets the safety endpoint compared with the conventional surgical strategy entailing left mammary artery grafting plus great saphenous vein grafts to revascularize the remaining coronary targets. The tertiary study hypothesis is that the BIMA grafting yields better follow-up results in terms of recurrence of symptoms related to coronary disease, of repeat revascularization and of cardiac mortality compared with patients treated with the conventional surgical strategy entailing left mammary artery grafting plus great saphenous vein grafts to revascularize the remaining coronary targets.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patiens undergoing primary or elective-urgent isolated multivessel Coronary Artery Bypass Grafting (CABG) Surgery

排除标准

  • Emergency status
  • Previous cardiac operation
  • Any associated cardiac procedure other than CABG Surgery
  • Left Ventricular Ejection Fraction <20%

结局指标

主要结局

Feasibility of systematic BIMA grafting

时间窗: 2012-2014 (2 years)

Starting in June 2012, all clinical data concerning patients undergoing BIMA grafting are recorded, including the baseline demographics and risk factors, the operative time, all in-hospital complications, duration of Intensive care Unit and Hospital stays, the amount of transfusion of blood products.

次要结局

  • Clinical results at follow-up(2012-2016 (4 years))

研究者

发起方
Catholic University, Italy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mario Gaudino

Researcher at Cardiac Surgery University Department

Catholic University, Italy

研究点 (1)

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