FrailtyMINIFRAGILENCT07742475
Funcional Recovery After Minithoracotomy or Sternotomy for CABG in Frail Patients
A study testing Minimally Invasive Coronary Artery Bypass Grafting (MICS-CABG) and Conventional Coronary Artery Bypass Grafting (Median Sternotomy) in people with Frailty and Coronary Artery Disease, run by University of Sao Paulo General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Frailty, Coronary Artery Disease, Coronary Artery Bypass Graft (CABG)
- What is being tested?
- Minimally Invasive Coronary Artery Bypass Grafting (MICS-CABG) and Conventional Coronary Artery Bypass Grafting (Median Sternotomy)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- Self-reported exhaustion or fatigue.
- Reduced handgrip strength.
- Slow walking speed.
- Low level of physical activity.
- Ability and willingness to provide written informed consent.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Functional Recovery After Coronary Artery Bypass Graft Surgery in Frail Patients: Randomized Clinical Trial Between Minithoracotomy Versus Sternotomy.
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.
- Being tested
- Minimally Invasive Coronary Artery Bypass Grafting (MICS-CABG), Conventional Coronary Artery Bypass Grafting (Median Sternotomy)
- Keywords
- Coronary Artery Bypass Grafting, Minimally Invasive Coronary Surgery, Minithoracotomy, Frailty, Functional Recovery
- Medical subject headings
- Frailty, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally Invasive Coronary Artery Bypass Grafting (MICS-CABG)Procedure or surgery
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 or surgery
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Conventional Coronary Artery Bypass Grafting (Median Sternotomy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (22)
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.
Measured: Up to 30 days after surgery
All-Cause Mortality
Percentage of participants who die from any cause within 30 days after the index surgical procedure.
Measured: Up to 30 days after surgery
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.
Measured: Up to 30 days after surgery
Stroke
Percentage of participants experiencing a new focal neurological deficit without complete spontaneous resolution within 24 hours after onset
Measured: Up to 30 days after surgery
Repeat Coronary Revascularization
Percentage of participants requiring repeat surgical or percutaneous coronary revascularization after the index procedure. This includes surgical revision or creation of coronary anastomoses and percutaneous coronary intervention performed after the index surgery.
Measured: Up to 30 days after surgery
Postoperative Angina
Percentage of participants reporting postoperative angina. Angina is defined as retrosternal chest discomfort, with or without radiation, that worsens with exertion and/or improves with vasodilator therapy and is neither pleuritic nor reproducible by chest-wall palpation.
Measured: Up to 30 days after surgery
Duration of Mechanical Ventilation
Time, measured in hours, from postoperative admission to the intensive care unit while receiving invasive mechanical ventilation until the first successful extubation.
Measured: Up to 30 days after surgery
Prolonged Mechanical Ventilation
Percentage of participants requiring invasive mechanical ventilation for more than 24 hours after admission to the intensive care unit.
Measured: Up to 30 days after surgery
Intensive Care Unit Length of Stay
Time, measured in hours, from postoperative admission to the intensive care unit until documentation that the participant meets the prespecified criteria for discharge from the intensive care unit.
Measured: Up to 30 days after surgery
Hospital Length of Stay
Time, measured in hours, from hospital admission for the index surgical procedure until documentation that the participant meets the prespecified objective criteria for hospital discharge.
Measured: Up to 30 days after surgery
Time to Return to Usual Activities
Number of days from the index surgery until the participant reports returning to the same or a better level of usual activities or functional status compared with the preoperative level.
Measured: Up to 30 days after surgery
Postoperative Pain Intensity
Postoperative pain intensity measured using an 11-point Numeric Rating Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Pain scores will be assessed separately on postoperative days 1, 2, and 3.
Measured: Postoperative days 1, 2, and 3
Deep Surgical Site Infection
Percentage of participants with a deep surgical site infection involving the primary thoracic surgical incision. Infection will be identified by compatible clinical findings, such as fever, purulent drainage, wound instability, or deep tissue involvement, and confirmed by imaging, microbiological testing, surgical findings.
Measured: Up to 30 days after surgery
Acute Kidney Injury
Percentage of participants developing acute kidney injury, defined as an increase in serum creatinine of at least 0.3 mg/dL within 48 hours after surgery.
Measured: Up to 48 hours after surgery
Reoperation
Percentage of participants requiring an additional surgical procedure to revise the index coronary revascularization, treat a complication caused by the index procedure, or re-enter the chest through the original or an alternative surgical access.
Measured: Up to 30 days after surgery
Conversion to Median Sternotomy
Percentage of participants assigned to minimally invasive coronary artery bypass grafting who require intraoperative conversion from left minithoracotomy to median sternotomy for completion of the operation or management of a complication.
Measured: Intraoperative period
Complete Coronary Revascularization
Percentage of participants in whom all coronary targets included in the final preoperative revascularization plan are successfully treated during the index procedure, either surgically or as part of a planned hybrid revascularization strategy, as documented in the operative and procedural records.
Measured: Intraoperative period
Adherence to Enhanced Recovery Measures
Number of prespecified enhanced recovery measures successfully completed for each participant, ranging from 0 to 5. The measures are: abbreviated preoperative fasting, avoidance of preoperative sedatives or anxiolytics, opioid-sparing anesthesia, regional anesthesia before or after surgery, and extubation within 6 hours after intensive care unit admission. Higher scores indicate greater protocol adherence.
Measured: From hospital admission to 6 hours after admission to postoperative intensive care unit
Extubation Within 6 Hours
Percentage of participants successfully extubated within 6 hours after postoperative admission to the intensive care unit.
Measured: Up to 6 hours after intensive care unit admission
All-Cause Hospital Readmission
Percentage of participants readmitted to any hospital for any reason after discharge from the index hospitalization. Transfers to a supporting hospital solely for warfarin dose adjustment will not be classified as readmissions.
Measured: Up to 30 days after surgery
Short Hospital Stay
Percentage of participants with an index hospital stay of fewer than 6 days.
Measured: Up to 6 days after surgery
Prolonged Hospital Stay
Percentage of participants with an index hospital stay of more than 14 days.
Measured: Up to 14 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Nacional de Cardiologia de Laranjeiras, Hospital e Maternidade Angelina Caron - SC, Santa Casa de Misericórdia de Maceió, Sancta Maggiore Itaim Hospital, Hospital Sao Vicente de Paulo e Hospital de Cidade, Passo Fundo, Brasil, Hospital Clínica Kennedy, Hospital Alberto Urquiza Wanderley
- Responsible party
- Sponsor
- Investigators
- Omar A V Mejia, MD PhD MBA, Study director, Instituto do Coração (Incor-HCFMUSP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742475
- Sponsor's protocol ID
- SDC6277/26/034
- Acronym
- MINIFRAGILE
- Status last verified
- May 2026
- First submitted
- 15 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Recovery After Coronary Artery Bypass Graft Surgery in Frail Patients: Randomized Clinical Trial Between Minithoracotomy Versus Sternotomy.
- ClinicalTrials.gov ID
- NCT07742475
- Acronym / sponsor ID
- MINIFRAGILE / SDC6277/26/034
- Keywords
- Coronary Artery Bypass Grafting, Minimally Invasive Coronary Surgery, Minithoracotomy, Frailty, Functional Recovery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Instituto Nacional de Cardiologia de Laranjeiras, Hospital e Maternidade Angelina Caron - SC, Santa Casa de Misericórdia de Maceió, Sancta Maggiore Itaim Hospital, Hospital Sao Vicente de Paulo e Hospital de Cidade, Passo Fundo, Brasil, Hospital Clínica Kennedy, Hospital Alberto Urquiza Wanderley
- Study start
- Sep 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Minimally Invasive Coronary Artery Bypass Grafting (MICS) | Experimental | Procedure: Minimally Invasive Coronary Artery Bypass Grafting (MICS-CABG)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 | Active comparator | Procedure: Conventional Coronary Artery Bypass Grafting (Median Sternotomy)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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally Invasive Coronary Artery Bypass Grafting (MICS-CABG)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 or surgery | Minimally Invasive Coronary Artery Bypass Grafting (MICS) |
| Conventional Coronary Artery Bypass Grafting (Median Sternotomy)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 or surgery | Conventional Coronary Artery Bypass Grafting |
Primary outcome
Change From Baseline in the SF-36 Physical Component Summary Score at 30 Days
Time frame: 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.
22 secondary outcomes
Incidence of Major Adverse Cardiovascular and Cerebrovascular Events
Time frame: Up to 30 days after surgery
All-Cause Mortality
Time frame: Up to 30 days after surgery
Perioperative Myocardial Infarction
Time frame: Up to 30 days after surgery
Stroke
Time frame: Up to 30 days after surgery
Repeat Coronary Revascularization
Time frame: Up to 30 days after surgery
Postoperative Angina
Time frame: Up to 30 days after surgery
Duration of Mechanical Ventilation
Time frame: Up to 30 days after surgery
Prolonged Mechanical Ventilation
Time frame: Up to 30 days after surgery
Intensive Care Unit Length of Stay
Time frame: Up to 30 days after surgery
Hospital Length of Stay
Time frame: Up to 30 days after surgery
Time to Return to Usual Activities
Time frame: Up to 30 days after surgery
Postoperative Pain Intensity
Time frame: Postoperative days 1, 2, and 3
Deep Surgical Site Infection
Time frame: Up to 30 days after surgery
Acute Kidney Injury
Time frame: Up to 48 hours after surgery
Reoperation
Time frame: Up to 30 days after surgery
Conversion to Median Sternotomy
Time frame: Intraoperative period
Complete Coronary Revascularization
Time frame: Intraoperative period
Adherence to Enhanced Recovery Measures
Time frame: From hospital admission to 6 hours after admission to postoperative intensive care unit
Extubation Within 6 Hours
Time frame: Up to 6 hours after intensive care unit admission
All-Cause Hospital Readmission
Time frame: Up to 30 days after surgery
Short Hospital Stay
Time frame: Up to 6 days after surgery
Prolonged Hospital Stay
Time frame: Up to 14 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Omar A V Mejia, MD PhD MBA study director
Instituto do Coração (Incor-HCFMUSP)
Questions about this trial
What is this clinical trial studying?
A study testing Minimally Invasive Coronary Artery Bypass Grafting (MICS-CABG) and Conventional Coronary Artery Bypass Grafting (Median Sternotomy) in people with Frailty and Coronary Artery Disease, run by University of Sao Paulo General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabio A S Lima Junior, MD (+551126615014, fabioserrajr@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the SF-36 Physical Component Summary Score at 30 Days (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.