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New balloon trick may save heart muscle during heart attacks

NCT ID NCT07646977

Disease control Sponsor: Odense University Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Sep 03, 2026 · Updated 3 times

Summary

This study tests a simple balloon inflation technique to modify blood clots during emergency heart artery opening. 100 heart attack patients will either get the balloon procedure or standard care. The goal is to see if this reduces damage to the heart muscle and improves recovery after 3 months.

What this could mean

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

Active substance
balloon inflation procedure
What this could lead to
If it works, this could lead to a simple technique that reduces heart muscle damage during heart attack treatment, potentially improving recovery.
What could go wrong
This is a small, early-phase study with only 100 participants, so results may not apply to everyone. The procedure may not improve outcomes or could cause complications.

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 100 people

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

Started

Jul 2026

Expected to finish

Jan 2034

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

18 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: * ST-elevation at the J-junction in a minimum of two contiguous ECG leads with a minimum of ≥ 0.1 mV in all leads, except for V2 and V3 (which required ≥ 0.2 for men ≥ 40 years old, ≥ 0.25 in men \< 40 years old, or ≥ 0.15 mV for all women) or new left bundle branch * Admission to hospital within 12 hours of symptom debut * Angiographic signs of a culprit lesion planned to be treated with primary percutaneous coronary intervention Exclusion Criteria: * Age \< 18 years or inability to provide informed consent * Life expectancy of \< 12 months * Hemodynamically instability * Pregnancy or breastfeeding * Known asthma or severe chronic obstructive pulmonary disease * Expected inability to perform physiological measurements (due to severely tortuous arteries, ostial disease or very distal disease), * CMR contraindications (estimated glomerular filtration rate \< 30 mL/min, magnetic or mechanically activated implants, or any prior metal implants, severe claustrophobia) * Expected to or unavoidable to use thrombectomy

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Conditions

The condition(s) this trial relates to.

coronary microvascular disorder ST-elevation myocardial infarction

As listed by the trial registrant

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

Coronary microvascular dysfunction Percutaneous coronary intervention ST elevation myocardial infarction

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Odense University Hospital

    RECRUITING

    Odense, Denmark

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