New imaging tool may predict heart attack risk
NCT ID NCT06374498
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
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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
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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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.
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The places running it
1 site. The list below names each one and where it is.
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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.
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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
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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