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Heart attack aftermath: new imaging method may spot hidden danger zones better than standard tests

NCT ID NCT05027984

Disease control Sponsor: Centro per la Lotta Contro l'Infarto - Fondazione Onlus 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This trial tests whether using a special camera inside the arteries (optical coherence tomography, or OCT) is better than standard pressure-wire measurements for deciding which non-blocked arteries need stenting in people who have just had a heart attack. About 1,425 participants will be randomly assigned to one of the two methods. The goal is to see which approach better prevents future heart-related deaths or heart attacks in the treated arteries.

What this could mean

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

Active substance
Optical coherence tomography (OCT) imaging and physiology-based measurements (iFR/FFR/RFR) to guide treatment decisions
What this could lead to
If successful, this could establish a more precise way to identify dangerous artery plaques, potentially preventing future heart attacks and deaths in patients who have already had one.
What could go wrong
The trial is large but still experimental; the OCT-guided approach may not prove better than standard physiology-guided care, and there are risks from additional imaging or unnecessary stenting.

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

1,425 people

The number who actually took part.

Started

Jun 2021

Expected to finish

Mar 2030

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: * Age of at least 18 years. * Diagnosis of acute coronary syndrome. * Single or multiple intermediate lesions in intervention-naïve major coronary segments (diameter ≥2.5 mm) determining a 40-70% diameter stenosis by visual assessment with no other significant stenosis (\>70%) in the same vessel. * Patient informed of the nature of the study, agreeing to it, and providing written informed consent as approved by the Ethics Committee of the respective clinical study site. * Life expectancy \>3 years. Exclusion criteria: * Female with childbearing potential or lactating. * Acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl). * Advanced heart failure (NYHA III-IV) * Stroke within the previous 6 months or spontaneous intracranial hemorrhage at any time. * Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial. * Coronary anatomy preventing complete imaging of the segment of interest (including at least 5 mm at both stenosis edges). * Lesions located in the left main coronary artery * Diffusely diseased coronary artery segment or presence of ≥1 significant untreated non-culprit lesions (preventing correct adverse event attribution) in the coronary arteries. * Prior myocardial infarction or coronary artery bypass graft \[CABG\] or PCI revascularization in the target coronary vessel. * Coronary anatomy unsuitable for PCI. * Comorbidities that might interfere with completion of the study procedures. * Planned major surgery necessitating interruption of dual antiplatelet. * Participating in another investigational drug or device trial that has not completed the primary endpoint or would interfere with the endpoints of this study.

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Conditions

The condition(s) this trial relates to.

acute coronary syndrome coronary artery disorder Coronary Disease myocardial ischemia

As listed by the trial registrant

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

Coronary artery disease Coronary disease Ischemic heart disease

Contacts and locations

Locations

  • ARNAS Brotzu

    Cagliari, CA, 09047, Italy

  • ASST Papa Giovanni XXIII

    Bergamo, BG, 24127, Italy

  • Azienda Ospedaliera "Policlinico "G. Rodolico- San Marco"

    Catania, CT, 95123, Italy

  • Azienda Ospedaliera Per L'emergenza Cannizzaro

    Catania, CT, 95126, Italy

  • Azienda Ospedaliera San Pio

    Benevento, BN, 82100, Italy

  • Azienda Ospedaliero Universitaria Policlinico "G. Martino", Messina

    Messina, ME, 98124, Italy

  • Azienda Ospedaliero_Universitaria IRCCS Policlinico di St.Orsola

    Bologna, BO, 40138, Italy

  • Azienda Sanitaria Universitaria Friuli Centrale - Udine University Hospital

    Udine, UD, 33100, Italy

  • Centro Cardiologico Monzino IRCCS

    Milan, MI, 20138, Italy

  • Di Venere Hospital

    Bari, BA, 70131, Italy

  • Ente ecclesiastico Ospedale Regionale Generale "F. Miulli"

    Acquaviva delle Fonti, BA, 70021, Italy

  • Federico II di Napoli

    Naples, 80138, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, RM, 00168, Italy

  • Hospital Universitario Central de Asturias

    Oviedo, 33011, Spain

  • Hospital Virgen de la Victoria

    Málaga, MA, 29010, Spain

  • Hospital universitario La Princesa, Madrid

    Madrid, M, 28006, Spain

  • IRCCS Casa sollievo della sofferenza

    San Giovanni Rotondo, FG, 71013, Italy

  • IRCCS Galeazzi- Sant'Ambrogio

    Milan, MI, 20157, Italy

  • IRCCS Ospedale Policlinico San Martino

    Genova, GE, 16132, Italy

  • Inselspital, Bern University Hospital

    Bern, Canton of Bern, 3010, Switzerland

  • Misericordia Hospital

    Grosseto, GR, 58100, Italy

  • Ospedale C. e G. Mazzoni

    Ascoli Piceno, AP, 63100, Italy

  • Ospedale Conegliano

    Conegliano, TV, 31015, Italy

  • Ospedale Santa Maria Goretti, Latina

    Latina, LT, 04100, Italy

  • Ospedale Vito Fazzi

    Lecce, LE, 73100, Italy

  • P.O. San Giuseppe Moscati

    Aversa, CE, 81031, Italy

  • P.O. Umberto I

    Syracuse, SR, 96100, Italy

  • Policlinico University Hospital

    Bari, BA, 70120, Italy

  • Rivoli Hospital

    Rivoli, TO, 10098, Italy

  • San Camillo Hospital

    Roma, RM, 00152, Italy

  • San Giovanni Hospital

    Rome, Rome, 00184, Italy

  • Struttura Complessa di Cardiologia Clinica e Interventistica

    Sassari, SS, 07100, Italy

  • UOSA Cardiologia Interventistica

    Siena, SI, 53100, Italy

  • University Hospital of Patras

    Pátrai, AX, 26504, Greece

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