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Wire-Free heart scan could cut unnecessary stents in heart attack patients

NCT ID NCT07598565

Disease control Sponsor: University of Roma La Sapienza 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a new wire-free imaging method called μFR can help doctors decide which blocked heart arteries need stents after a heart attack. About 350 patients with multiple blocked arteries will be randomly assigned to standard care or μFR-guided treatment. The goal is to see if μFR reduces the number of stents and procedures without increasing heart problems.

What this could mean

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

Active substance
μFR (Murray-law-based quantitative flow ratio) as a diagnostic tool to guide revascularization decisions
What this could lead to
If successful, this could lead to fewer unnecessary stents and procedures for heart attack patients, improving outcomes and reducing risks.
What could go wrong
This is an early-stage trial with only 350 participants, so results may not apply to all patients. The μFR method may not accurately identify which blockages need treatment.

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 350 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: 1. Patients presenting with ACS within 72 hours of successful culprit PCI 2. Residual coronary artery disease, defined as at least one additional stenosis in any non-culprit vessel (NCV) with the following characteristics: 1. at least 50% diameter stenosis by visual assessment 2. a vessel diameter of at least 2.5 mm 3. amenable to successful PCI Exclusion Criteria: 1. Cardiogenic shock or severe heart failure (NYHA class ≥III) 2. Severely impaired renal function: creatinine \>2 mg/dl or estimated glomerular filtration rate (eGFR) \<30 ml/min/1,73 m² 3. Allergy to iodine-containing contrast agents which cannot be adequately pre-medicated 4. Pregnancy or intention to become pregnant during the trial 5. Life expectancy less than one year 6. Ambiguity in the identification of the culprit vessel/lesion 7. Clinical presentation as myocardial infarction and non-obstructive coronary artery disease (MINOCA) and/or Tako-Tsubo Syndrome 8. Any ambiguity in the diagnosis of ACS 9. Inability to provide informed consent 10. Patients with only one coronary artery lesion with diameter stenosis \>90% and/or TIMI flow \<3 11. Patients in whom the NCV is treated at the time of the index procedure 12. An interrogated lesion is at the site of a myocardial bridge 13. An interrogated lesion is a culprit lesion responsible for the acute myocardial infarction 14. An interrogated lesion is in a bypass graft 15. Poor angiographic image quality precluding vessel contour detection or with suboptimal contrast opacification 16. Severe vessel overlap in the stenosed segment or severe tortuosity of any interrogated vessel deemed not amenable to μFR measurement

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Conditions

The condition(s) this trial relates to.

acute coronary syndrome acute myocardial infarction coronary artery disorder myocardial infarction ST-elevation myocardial infarction

As listed by the trial registrant

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

Acute coronary syndromes (ACS) Multivessel coronary artery disease Nstemi - non-ST-segment elevation myocardial infarction Stemi - 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

  • Azienda ospedaliero - universitaria Sant'Andrea

    Roma, RM, 00189, Italy

More trials for these conditions

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