A randomised comparative study of patients undergoing myocardial revascularisation with or without cardiopulmonary bypass surgery

Zerbini Foundation (Fundação Zerbini) (Brazil)0 个研究点目标入组 311 人2008年3月10日

概览

阶段: 未知
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: Zerbini Foundation (Fundação Zerbini) (Brazil)
入组人数: 311
状态: 已完成
最后更新: 3年前

概览研究者入排标准结局指标相似试验

概览

简要总结

2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25096030 results 2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24855193 results 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36536451/ Long-term analysis (added 20/12/2022)

注册库

who.int

开始日期

2008年3月10日

结束日期

2010年1月31日

最后更新

3年前

研究类型

Interventional

性别

All

研究者

发起方

Zerbini Foundation (Fundação Zerbini) (Brazil)

入排标准

入选标准

•1\. Male or female, age 18 years or older
•2\. Patients with stable angina pectoris and/or documented ischemia due to multivessel disease and preserved ventricular function
•3\. Angiographically confirmed multivessel coronary artery disease (CAD) with \>\=70% lesions in at least two major epicardial vessels and at least two separate coronary artery territories (LAD, LCX and RCA)
•4\. Patients who are eligible for coronary surgery both with and without cardiopulmonary bypass circuit
•5\. Willing to comply with all follow\-up study visits
•6\. Signed and received a copy of the informed consent
•Note: Non\-significant left main stenoses can be included

排除标准

•1\. Age under 18 years
•2\. Severe congestive hearth failure, New York Heart Association (NYHA) Class III or IV, or pulmonary edema
•3\. Prior valve replacement or coronary artery bypass graft (CABG) surgery
•4\. Prior percutaneous coronary intervention (PCI) with stent implantation within 6 months
•5\. Prior stroke within 6 months or patients with stroke that occurred more than 6 months ago with significant residual neurological involvement, as reflected in a Rankin score \>\= 1
•6\. Need for concomitant major surgery e.g. valve replacement, resection ventricular aneurysm, congenital heart disease vascular surgery of the carotid artery, or thoracic\-abdominal aorta
•7\. Concomitant medical disorders making clinical follow\-up at least 5 years unlikely or impossible e.g. neoplastic, hepatic, or other severe disease
•8\. Q\-wave myocardial infarction in the previous 6 weeks
•9\. Hemorrhagic diathesis or hypercoagulability
•10\. Thoracic deformations technically precluding surgery without extracorporeal circulation

结局指标

主要结局

未指定

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