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Off-pump Versus On-pump Coronary Artery Bypass Grafting in Frail Patients — FRAGILE  

Coronary Artery Disease Clinical Trial

Official title:
A Multicenter, Prospective, Randomized, Clinical Trial Comparing Off-pump Versus On-pump Coronary Artery Bypass Grafting in Frail Patients

Clinical Trial Summary

Frailty is defined as a geriatric syndrome of impaired resiliency to stressors (such as cardiac surgery) that has been delineated recently in the cardiovascular literature. One of the most controversial areas of cardiac surgery has been whether off-pump coronary artery bypass grafting (OPCAB) surgery is superior to conventional on-pump coronary artery bypass grafting (CABG) surgery. There is an ongoing debate about the benefits and disadvantages of OPCAB surgery and we believe that this remains an important technique for the improvement of coronary surgery. The benefits of CABG surgery in frail patients are still undetermined. The aim of this study is to clarify the potential benefit of OPCAB surgery in pre-frail and frail patients by comparing off-pump versus on-pump CABG in these patients.

Clinical Trial Description

The FRAGILE protocol is a national multicenter randomized controlled trial (RCT), conducted in 8 Brazilian institutions. The study is already approved by a certified ethics committee. Funding is provided by a grant from São Paulo Research Foundation (FAPESP), which otherwise will not have any role in the conduct of the study nor in the analysis nor in the reporting of data. A confidentiality agreement regarding data use and the data safety will be monitored by an independent monitoring board. All the authors will provide revisions and comments and be testifying for the accuracy and completeness of the report, as well as for the fidelity of the report to the study protocol. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02338947
Study type Interventional
Source University of Sao Paulo General Hospital
Contact Omar AV Mejia, MD, PhD
Phone 55(11) 996862043
Email omar.mejia@incor.usp.br
Status Recruiting
Phase N/A
Start date January 1, 2019
Completion date December 31, 2021
View Details
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