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Can a smaller incision speed recovery after heart bypass in frail seniors?

NCT ID NCT07742475

Disease control Sponsor: University of Sao Paulo General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 03, 2026 · Last updated Aug 06, 2026 · Updated 3 times

Summary

This trial tests whether a minimally invasive heart bypass surgery, done through a small incision on the left side of the chest, helps frail adults aged 60 and older recover better than the traditional approach of opening the breastbone. Participants are randomly assigned to one of the two surgical methods. The main goal is to see if the less invasive approach improves physical functioning 30 days after surgery, with secondary checks on complications, hospital stay, pain, and return to normal activities.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Minimally invasive coronary artery bypass grafting (MICS-CABG) through a left anterior minithoracotomy
What this could lead to
If successful, this could establish a less invasive surgical approach that helps frail older adults recover faster and return to daily activities sooner after heart bypass surgery.
What could go wrong
The trial is still in progress, and results may not show a clear benefit. Minimally invasive surgery carries risks such as bleeding, infection, or incomplete revascularization, and the benefits may not apply to all frail patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 194 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder Frailty

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coronary artery bypass graft (CABG) Coronary artery disease Frailty

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.