Funcional Recovery After Minithoracotomy or Sternotomy for CABG in Frail Patients

NCT07742475 | Not Yet Recruiting

• 1 other identifier: SDC6277/26/034
• Study Type: interventional
• Target: 194
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Keywords

Coronary Artery Bypass Grafting; Minimally Invasive Coronary Surgery; Minithoracotomy; Frailty; Functional Recovery

Outcome Measures

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.

  30 days

Secondary Outcomes (22)

• Incidence of Major Adverse Cardiovascular and Cerebrovascular Events

  Up to 30 days after surgery

• All-Cause Mortality

  Up to 30 days after surgery

• Perioperative Myocardial Infarction

  Up to 30 days after surgery

• Stroke

  Up to 30 days after surgery

• Repeat Coronary Revascularization

  Up to 30 days after surgery

Study Arms (2)

Minimally Invasive Coronary Artery Bypass Grafting (MICS)

EXPERIMENTAL

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.

Procedure: Minimally Invasive Coronary Artery Bypass Grafting (MICS-CABG)

Conventional Coronary Artery Bypass Grafting

ACTIVE COMPARATOR

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.

Procedure: Conventional Coronary Artery Bypass Grafting (Median Sternotomy)

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.

Minimally Invasive Coronary Artery Bypass Grafting (MICS)

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.

Conventional Coronary Artery Bypass Grafting

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.;
• \> Alternatively, coronary anatomy suitable for a planned hybrid revascularization strategy, with coronary territories not treated surgically considered amenable to percutaneous coronary intervention.
• Presence of pre-frailty or frailty, defined by at least 2 of the following Fried frailty criteria:
• Unintentional weight loss of at least 4.5 kg or at least 5% of body weight during the previous year.
• Self-reported exhaustion or fatigue.
• Reduced handgrip strength.
• Slow walking speed.
• Low level of physical activity.
• Ability and willingness to provide written informed consent.

You may not qualify if:

• 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.
• Severe chronic obstructive pulmonary disease or another pulmonary condition that prevents safe single-lung ventilation or temporary compression of the left lung.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• 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

MeSH Terms

Conditions

Frailty; Coronary Artery Disease

Interventions

Sternotomy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Thoracic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Omar A V Mejia, MD PhD MBA

  Instituto do Coração (Incor-HCFMUSP)

  STUDY DIRECTOR

Central Study Contacts

Fabio A S Lima Junior, MD

CONTACT

+551126615014; fabioserrajr@outlook.com

Omar A V Mejia, MD PhD MBA

CONTACT

+551126615014; omar.mejia@incor.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Because of the nature of the surgical interventions, neither participants nor treating clinicians can be blinded to treatment allocation. Patient-reported quality-of-life assessments and clinical outcomes will be collected according to standardized study procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1 ratio to undergo coronary artery bypass grafting either through a minimally invasive left anterior minithoracotomy or through conventional median sternotomy. Participants will receive only the assigned intervention and will be followed prospectively for assessment of functional recovery, quality of life, and perioperative clinical outcomes.

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: August 3, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 5, 2026

Record last verified: 2026-05