Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New imaging tool may predict heart attack risk

NCT ID NCT06374498

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 14, 2026 · Updated 4 times

Summary

This study tests a new imaging device called OCT-NIRAF that takes detailed pictures inside heart arteries during a standard heart procedure. Researchers want to see if the images can predict which plaques (fatty buildups) will grow and become dangerous. Forty adults with heart disease will be scanned at the start and again after one year. The goal is to better understand how plaques progress, not to treat them directly.

What this could mean

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

What this could lead to
If successful, this could lead to a new way to predict which heart artery plaques are dangerous, helping doctors decide on treatments earlier.
What could go wrong
This is a small, early study with only 40 people, so results may not apply to everyone. It is designed to gather knowledge, not to test a 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 70 people

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

Started

Jul 2024

Expected to finish

Apr 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

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.

Arm 1: Inclusion Criteria: * Participants with stable CAD or acute coronary syndromes undergoing invasive coronary angiography in the MGH cardiac catheterization laboratory * Participant is eligible for PCI * Participants must be over the age of 18 * Participant must be able to give informed consent * Women with childbearing potential must have a negative pregnancy test within seven days prior to the procedure Exclusion Criteria: * CLINICAL EXCLUSION CRITERIA: * Renal insufficiency (GRF\<45 ml/min/1.73m2) * Pregnancy * Acute myocardial infarction: Participants with ST elevation MI will be excluded for at least 72 hours post event. Participants with non-ST elevation MI will be excluded if they have evidence of ongoing ischemia defined as chest pain or new ECG changes in the previous 12 hours and/or rising cardiac biomarker enzymes (e.g., troponin or CKMB) * Evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure \<90 mmHg, and severe congestive heart failure (NYHA III or IV) or acute pulmonary edema, * Emergent procedures * Ejection fraction \<= 35% * Clinically significant bleeding within the past 14 days * Any active, serious, life-threatening disease with a life expectancy of less than 12 months * Inability to be evaluated at follow-up * Currently enrolled in another study utilizing OCT imaging, or in an investigational trial that involves a non-approved cardiac drug or device * Participants under the protection of justice, guardianship, or curatorship CARDIAC CATHETERIZATION LABORATORY - EXCLUSION CRITERIA (AFTER DIAGNOSTIC CORONARY ANGIOGRAM): * Participant deemed not indicated for intravascular imaging or PCI * Inability to perform intravascular imaging of a target artery * Left main disease \>= 50% stenosis in participants that do not have a functioning LAD bypass graft * Clinical instability that develops after IVUS imaging but prior to OCT-NIRAF imaging Arm 2: Because of the additional injection of LUMISIGHT, the following exclusion criteria (in addition to the criteria above) will be added: ADDITIONAL EXCLUSION CRITERIA: * Renal insufficiency (GRF \<60 ml/min /1.73m2 ) * History of hypersensitivity to pegulicianine * History of allergic reaction to oral or intravenous contrast agents * History of allergic reaction to polyethylene glycol (PEG) * History of any documented allergic or anaphylactic reactions i.e to drugs or food (eggs, shellfish etc.) or chemicals (rubber, latex etc.) or other clinically significant allergies * Patients who have taken an investigational drug within 14 days of enrollment * Patients with uncontrolled hypertension defined as persistent systolic blood pressure \> 180 mm Hg, or diastolic blood pressure \> 110 mm Hg; those subjects with known HTN should be under these values while under pharmaceutical therapy * Severe concurrent illnesses including, but not limited to ongoing or major or severe active infections, symptomatic congestive heart failure, COPD or asthma requiring hospitalization within the past 12 months, or psychiatric illness/social situations that would limit compliance with study requirements.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Cardiovascular diseases are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

More trials for these conditions

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