Off-pump vs On-pump Surgery for Coronary Artery Disease
(FRAGILE Trial)
What You Need to Know Before You Apply
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is off-pump coronary artery bypass surgery safe compared to on-pump surgery?
How does off-pump coronary artery bypass grafting differ from on-pump surgery for coronary artery disease?
Off-pump coronary artery bypass grafting is unique because it avoids the use of a heart-lung machine (cardiopulmonary bypass), which can reduce inflammation and other complications associated with the machine. This method can be technically more challenging but may lead to fewer adverse events compared to the traditional on-pump approach.36789
What data supports the effectiveness of the treatment Off-pump coronary-artery bypass grafting compared to On-pump coronary-artery bypass grafting?
Who Is on the Research Team?
Omar AV Mejia, MD, PhD
Principal Investigator
InCor Heart Institute
Fábio B Jatene, MD, PhD
Principal Investigator
InCor Heart Institute
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo either off-pump or on-pump coronary artery bypass grafting surgery
Immediate Postoperative Monitoring
Participants are monitored for major adverse cardiac and cerebrovascular events, mechanical ventilation time, and other immediate postoperative outcomes
Follow-up
Participants are monitored for frailty status, neurobehavioral outcomes, graft patency, and quality of life
What Are the Treatments Tested in This Trial?
Interventions
- Off-pump coronary-artery bypass grafting
- On-pump coronary-artery bypass grafting
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Sao Paulo General Hospital
Lead Sponsor
Beneficência Portuguesa de São Paulo
Collaborator
Hospital das Clínicas Samuel Libânio
Collaborator
Clinical Hospital Samuel Libânio of Pouso Alegre
Collaborator
Hospital do Coração de Messejana Dr. Carlos Alberto Studart
Collaborator
Instituto Nacional de Cardiologia de Laranjeiras
Collaborator
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina de São Paulo
Collaborator
Hospital Alberto Urquiza Wanderley
Collaborator
Hospital Samaritano Campinas
Collaborator
Mount Sinai Hospital, New York
Collaborator