440 Participants Needed

Off-pump vs On-pump Surgery for Coronary Artery Disease

(FRAGILE Trial)

Recruiting at 10 trial locations
OA
BC
Overseen ByBianca C Meneghini, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Sao Paulo General Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Off-pump coronary artery bypass surgery is generally considered safe and has similar outcomes to on-pump surgery, with some studies suggesting it may have fewer adverse effects and improved outcomes, especially in high-risk patients.12345

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?

Research shows that off-pump surgery may lead to lower rates of complications like stroke and kidney failure, and patients often have shorter hospital stays and need fewer blood transfusions. However, some studies suggest that long-term survival might be better with on-pump surgery.1011121314

Who Is on the Research Team?

OA

Omar AV Mejia, MD, PhD

Principal Investigator

InCor Heart Institute

FB

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either off-pump or on-pump coronary artery bypass grafting surgery

Surgical procedure duration up to 600 minutes
1 visit (in-person for surgery)

Immediate Postoperative Monitoring

Participants are monitored for major adverse cardiac and cerebrovascular events, mechanical ventilation time, and other immediate postoperative outcomes

30 days
Inpatient stay including ICU monitoring

Follow-up

Participants are monitored for frailty status, neurobehavioral outcomes, graft patency, and quality of life

12 months
Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

  • Off-pump coronary-artery bypass grafting
  • On-pump coronary-artery bypass grafting
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: On-pump coronary-artery bypass grafting - CABGActive Control1 Intervention
Group II: Off-pump coronary-artery bypass grafting - OPCABActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Sao Paulo General Hospital

Lead Sponsor

Trials
567
Recruited
218,000+

Beneficência Portuguesa de São Paulo

Collaborator

Trials
20
Recruited
34,100+

Hospital das Clínicas Samuel Libânio

Collaborator

Trials
1
Recruited
440+

Clinical Hospital Samuel Libânio of Pouso Alegre

Collaborator

Trials
1
Recruited
440+

Hospital do Coração de Messejana Dr. Carlos Alberto Studart

Collaborator

Trials
1
Recruited
440+

Instituto Nacional de Cardiologia de Laranjeiras

Collaborator

Trials
14
Recruited
3,600+

Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina de São Paulo

Collaborator

Trials
1
Recruited
440+

Hospital Alberto Urquiza Wanderley

Collaborator

Trials
1
Recruited
440+

Hospital Samaritano Campinas

Collaborator

Trials
1
Recruited
440+

Mount Sinai Hospital, New York

Collaborator

Trials
37
Recruited
892,000+

Citations

Clinical and radiologic outcome of off-pump coronary surgery at 12 months follow-up: a prospective randomized trial. [2016]
Health-related quality of life outcome after on-pump versus off-pump coronary artery bypass graft surgery: a prospective randomized study. [2006]
Changes in health-related quality of life in off-pump versus on-pump cardiac surgery: Veterans Affairs Randomized On/Off Bypass trial. [2016]
Current practice and outcomes of off-pump multivessel coronary artery bypass. [2019]
Worse long-term survival after off-pump than on-pump coronary artery bypass grafting. [2022]
No major differences in 30-day outcomes in high-risk patients randomized to off-pump versus on-pump coronary bypass surgery: the best bypass surgery trial. [2010]
Ten-year outcome analysis of off-pump sequential grafting: single surgeon, single center experience. [2016]
Off-pump versus on-pump coronary artery bypass grafting. [2014]
Trainees operating on high-risk patients without cardiopulmonary bypass: a high-risk strategy? [2007]
Beating versus arrested heart revascularization: evaluation of myocardial function in a prospective randomized study. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Aborted off-pump coronary artery bypass patients have much worse outcomes than on-pump or successful off-pump patients. [2020]
12.United Statespubmed.ncbi.nlm.nih.gov
Off-pump versus on-pump coronary artery bypass grafting. [2021]
13.United Statespubmed.ncbi.nlm.nih.gov
Surgical volume and outcomes of off-pump coronary artery bypass graft surgery: Does it matter? [2009]
14.United Statespubmed.ncbi.nlm.nih.gov
Five-Year Outcomes after On-Pump and Off-Pump Coronary-Artery Bypass. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security