What this means
This trial will compare two ways of doing heart bypass surgery in frail patients. It has not started enrolling, so it cannot yet say which approach works better.
Plain-English summary written by an AI model from the registry listing.
- Status
- Opening soon
- Who can join
- Ages 60 and over
- Where
- Not listed
The science
- Registered title
- Funcional Recovery After Minithoracotomy or Sternotomy for CABG in Frail Patients
- Trial ID
- NCT07742475 ↗
- Phase
- Not applicable
- Study type
- interventional
- Conditions
- Frailty, Coronary Artery Disease, Coronary Artery Bypass Graft (CABG)
- What is tested
- Minimally Invasive Coronary Artery Bypass Grafting (MICS-CABG), Conventional Coronary Artery Bypass Grafting (Median Sternotomy)
- Sponsor
- University of Sao Paulo General Hospital
- Ages
- 60 Years to no maximum
- Dates
- First posted Aug 3, 2026 · updated Aug 5, 2026
Registry summary
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.