Off-pump vs On-pump Surgery for Coronary Artery Disease
(FRAGILE Trial)

Recruiting in Palo Alto (17 mi)

+10 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Sao Paulo General Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for patients aged 60 or older who need heart surgery to improve blood flow and meet at least two frailty criteria. It's not specified who can't join, but typically those with conditions making surgery too risky are excluded.

Inclusion Criteria

I am 60 or older, considered frail by specific criteria, and can have heart bypass surgery.

Participant Groups

The study compares two types of heart bypass surgery in frail elderly patients: one without stopping the heart (off-pump) and one with stopping the heart (on-pump). The goal is to see which method is better for these high-risk patients.

2Treatment groups

Active Control

Group I: On-pump coronary-artery bypass grafting - CABGActive Control1 Intervention

Pre-frail and frail patients will be randomly assigned to CABG after the evaluation of the target vessels by an internet-based, password protected database program. The surgery will be performed as described in the "intervention" section and the patients will be followed up for two years.

Group II: Off-pump coronary-artery bypass grafting - OPCABActive Control1 Intervention

Pre-frail and frail patients will be randomly assigned to OPCAB after the evaluation of the target vessels by an internet-based, password protected database program. The surgery will be performed as described in the "intervention" section and the patients will be followed up for two years.