About this trial
Frailty is a major predictor of adverse outcomes following coronary artery bypass grafting (CABG), being associated with increased postoperative complications, prolonged hospitalization, delayed functional recovery, and reduced quality of life. Although minimally invasive coronary surgery (MICS) through left minithoracotomy has been associated with reduced surgical trauma and faster recovery in selected patients, its benefits have not been evaluated in a randomized trial specifically involving frail patients.
The MINI FRAGILE trial is a prospective, multicenter, randomized, open-label clinical trial designed to compare minimally invasive CABG performed through left anterior minithoracotomy with conventional median sternotomy in patients aged 60 years or older with pre-frailty or frailty undergoing surgical coronary revascularization. Eligible participants will be randomized in a 1:1 ratio to either surgical approach.
The primary objective is to determine whether minimally invasive CABG improves functional recovery, assessed by the change in the physical component of the SF-36 Health Survey 30 days after surgery. Secondary outcomes include major adverse cardiovascular events, mortality, intensive care unit and hospital length of stay, duration of mechanical ventilation, return to usual activities, surgical site infection, perioperative complications, postoperative pain, readmission, and adherence to enhanced recovery measures. The results of this trial are expected to provide high-quality evidence regarding the optimal surgical approach for frail patients requiring coronary artery bypass grafting.
Eligibility criteria
Qualifiers
Age 60 years or older.
Diagnosis of coronary artery disease with an established indication for coronary artery bypass grafting.
Coronary anatomy considered suitable for complete surgical revascularization through a left anterolateral minithoracotomy, including suitable distal coronary targets with a luminal diameter of at least 1.5 mm.;
Unintentional weight loss of at least 4.5 kg or at least 5% of body weight during the previous year.
Disqualifiers
Requirement for emergency cardiac surgery.
Planned concomitant cardiac surgical procedure in addition to coronary artery bypass grafting.
Clinically significant peripheral vascular disease involving the femoral vessels that prevents safe peripheral cannulation for cardiopulmonary bypass, when peripheral cannulation may be required.
Contraindication to left minithoracotomy, including pleural adhesions, pleural thickening, or other thoracic conditions that prevent safe access to the mediastinum through the intercostal space.
Trial design
Treatments tested in this trial
- Minimally Invasive Coronary Artery Bypass Grafting (MICS-CABG)
- Conventional Coronary Artery Bypass Grafting (Median Sternotomy)
Treatment groups
Locations
Sponsors and collaborators
University of Sao Paulo General Hospital
Lead sponsor
Instituto Nacional de Cardiologia de Laranjeiras
Collaborator
Hospital e Maternidade Angelina Caron - SC
Collaborator
Santa Casa de Misericórdia de Maceió
Collaborator
Sancta Maggiore Itaim Hospital
Collaborator
Hospital Sao Vicente de Paulo e Hospital de Cidade, Passo Fundo, Brasil
Collaborator
Hospital Clínica Kennedy
Collaborator
Hospital Alberto Urquiza Wanderley
Collaborator