NCT02338947Active, not recruiting
Off-pump Versus On-pump Coronary Artery Bypass Grafting in Frail Patients
A Multicenter, Prospective, Randomized, Clinical Trial Comparing Off-pump Versus On-pump Coronary Artery Bypass Grafting in Frail Patients
Source: ClinicalTrials.gov · Last updated 5 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 440 (actual)
- First submitted
- 29 Aug 2014
- Start date
- 1 Jan 2019
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- University of Sao Paulo General Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT02338947
What you commit to
- Study type: Interventional
- Participants enrolled: 440
- From 1 Jan 2019 to the primary completion date, 31 Dec 2024
- 7 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- \- Patients with the indication of angioplasty or another procedure in addition to CABG; patients who underwent an emergency operation (within 24 hours after hospital admission); patients who underwent previous cardiac surgery, even with other approaches than median sternotomy; patients who do not have free, prior and informed consent to participate in this study.
Who the study is looking for
- \- Participants aged ≥60 years with the indication of myocardial revascularization with ≥2 criteria of frailty by Fried Frailty Criteria, and suitable to undergo either Off-pump or On-pump CABG.
Age in the registry: 60 years to - · Sex: All · Accepts healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital de Messejana Coordinator of this site? Confirm its status | Fortaleza | Brazil | Unknown status |
| Hospital Alberto Urquiza Wanderley Coordinator of this site? Confirm its status | João Pessoa | Brazil | Unknown status |
| Hospital das Clínicas Samuel Libânio Coordinator of this site? Confirm its status | Pouso Alegre | Brazil | Unknown status |
| Instituto Nacional de Cardiologia de Laranjeiras Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina de São Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Beneficencia Portuguesa de Sao Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Emory University School of Medicine Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.