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 人开始时间: 2008年3月10日最近更新: 2023年1月9日

试验速览

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)

•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

•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
•11. Unable to give informed consent

发起方

Zerbini Foundation (Fundação Zerbini) (Brazil)