Funcional Recovery After Minithoracotomy or Sternotomy for CABG in Frail Patients

Sponsor
University of Sao Paulo General Hospital
Study ID
NCT07742475
Status
Not Yet Recruiting

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Conditions

  • Coronary Artery Bypass Graft (CABG)
  • Coronary Artery Disease
  • Frailty

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Minimally Invasive Coronary Artery Bypass Grafting (MICS-CABG) — PROCEDURE
    Participants undergo coronary artery bypass grafting through a left anterior minithoracotomy with or without cardiopulmonary bypass, according to the surgical plan. Standardized perioperative enhanced recovery measures are applied.
  • Conventional Coronary Artery Bypass Grafting (Median Sternotomy) — PROCEDURE
    Participants undergo conventional coronary artery bypass grafting through median sternotomy with or without cardiopulmonary bypass according to institutional practice. Postoperative care follows standard institutional protocols.

Study Details

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.

Key Dates

First listed
Aug 3, 2026
Start date
Sep 30, 2026
Status verified
May 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
194 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Minimally Invasive Coronary Artery Bypass Grafting (MICS)
    Participants undergo coronary artery bypass grafting through a left anterior minithoracotomy with or without cardiopulmonary bypass, according to the surgical plan. Standardized perioperative enhanced recovery measures are applied.
  • Active Comparator: Conventional Coronary Artery Bypass Grafting
    Participants undergo conventional coronary artery bypass grafting through median sternotomy with or without cardiopulmonary bypass according to institutional practice. Postoperative care follows standard institutional protocols.

Primary Outcome Measure

Change From Baseline in the SF-36 Physical Component Summary Score at 30 Days [ Time Frame: 30 days ]

Central Contacts

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