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

Last updated: February 27, 2025
Sponsor: University of Sao Paulo General Hospital
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Hypercholesterolemia

Heart Disease

Treatment

On-pump coronary-artery bypass grafting

Off-pump coronary-artery bypass grafting

Clinical Study ID

NCT02338947
USaoPauloGH1000
Sao Paulo Research Foundation
  • Ages > 60
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Participants aged ≥60 years with the indication of myocardial revascularization with ≥2 criteria of frailty by Fried Frailty Criteria, and suitable to undergo eitherOff-pump or On-pump CABG.

Exclusion

Exclusion criteria:

  • Patients with the indication of angioplasty or another procedure in addition toCABG; patients who underwent an emergency operation (within 24 hours after hospitaladmission); patients who underwent previous cardiac surgery, even with otherapproaches than median sternotomy; patients who do not have free, prior and informedconsent to participate in this study.

Study Design

Total Participants: 440
Treatment Group(s): 2
Primary Treatment: On-pump coronary-artery bypass grafting
Phase:
Study Start date:
January 01, 2019
Estimated Completion Date:
December 31, 2025

Study Description

The FRAGILE protocol is a national multicenter randomized controlled trial (RCT), conducted in 6 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.

Connect with a study center

  • Hospital de Messejana

    Fortaleza, Ceará
    Brazil

    Site Not Available

  • Instituto de Cardiologia do Distrito Federal

    Brasília, DF 70658-700
    Brazil

    Site Not Available

  • Hospital das Clínicas Samuel Libânio

    Pouso Alegre, Minas Gerais 37550-000
    Brazil

    Site Not Available

  • Hospital Alberto Urquiza Wanderley

    João Pessoa, Paraiba 58040-300
    Brazil

    Site Not Available

  • Pontifícia Universidade Católica do Paraná

    Curitiba, Parana 80215-901
    Brazil

    Site Not Available

  • Pronto Socorro Cardiológico de Pernambuco

    Recife, Pernambuco 50100-010
    Brazil

    Site Not Available

  • Hospital Samaritano Campinas

    Campinas, SP 13041-304
    Brazil

    Site Not Available

  • Instituto Nacional de Cardiologia de Laranjeiras

    Rio De Janeiro, 22240-002
    Brazil

    Site Not Available

  • Beneficência Portuguesa de São Paulo

    São Paulo, 01323-001
    Brazil

    Site Not Available

  • Hospital Samaritano Paulista

    São Paulo, 01317-002
    Brazil

    Active - Recruiting

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

    São Paulo, 05403-900
    Brazil

    Site Not Available

  • Emory University School of Medicine

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Mount Sinai Hospital

    New York, New York 10029-6574
    United States

    Site Not Available

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