Funcional Recovery After Minithoracotomy or Sternotomy for CABG in Frail Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity of Sao Paulo General Hospital
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Minimally Invasive Coronary Artery Bypass Grafting (MICS-CABG)
Procedure/SurgeryParticipants 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/SurgeryParticipants undergo conventional coronary artery bypass grafting through median sternotomy with or without cardiopulmonary bypass according to institutional practice. Postoperative care follows standard institutional protocols.
Treatment groups
194 Participants
are divided into 2 treatment groupsGroup A: Minimally Invasive Coronary Artery Bypass Grafting (MICS)Experimental treatment 1 intervention
Group B: Conventional Coronary Artery Bypass GraftingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change From Baseline in the SF-36 Physical Component Summary Score at 30 Days
The Short Form-36 Health Survey, version 2 (SF-36v2), will be administered before surgery and 30 days after surgery. The primary outcome is the change in the Physical Component Summary score, calculated as the 30-day score minus the baseline score. SF-36 scores are transformed to a 0-to-100 scale, with higher scores indicating better self-reported physical health and functioning.
Time frame
30 daysSecondary outcomes
1
Incidence of Major Adverse Cardiovascular and Cerebrovascular Events
Percentage of participants experiencing at least one component of the composite outcome of perioperative myocardial infarction, angina, repeat coronary revascularization, or stroke. Each participant will be counted once in the composite, regardless of the number of events experienced. Perioperative myocardial infarction will be defined according to the prespecified study criteria using postoperative high-sensitivity troponin levels and evidence of new myocardial ischemia. Stroke will be defined as a focal neurological deficit without complete spontaneous resolution within 24 hours.
Time frame
Up to 30 days after surgery2
All-Cause Mortality
Percentage of participants who die from any cause within 30 days after the index surgical procedure.
Time frame
Up to 30 days after surgery3
Perioperative Myocardial Infarction
Percentage of participants experiencing perioperative myocardial infarction, defined as a postoperative high-sensitivity cardiac troponin concentration greater than 500 times the assay upper reference limit, or greater than 35 times the upper reference limit accompanied by evidence of new myocardial ischemia. Evidence of ischemia may include new ischemic electrocardiographic changes, documented coronary artery or graft occlusion, new loss of viable myocardium, or a new regional ventricular wall-motion abnormality.
Time frame
Up to 30 days after surgery4
Stroke
Percentage of participants experiencing a new focal neurological deficit without complete spontaneous resolution within 24 hours after onset
Time frame
Up to 30 days after surgeryLocations
Sponsors and contacts
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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
Source ClinicalTrials.gov
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