Studies a heart imaging device that detects inflamed plaque in coronary arteries

Trial details

Who runs it

Massachusetts General Hospital

Trial code

NCT06374498

Record updated

10 November 2026

Original description

There are 2 arms to this study.Read full original descriptionShow less

Study to Determine the Clinical Significance of Intravascular OCT-NIRAF

There are 2 arms to this study.

Arm 1: Participants undergoing coronary angiography for stable or acute coronary disease presentations and eligible for percutaneous coronary intervention (PCI) will be imaged with OCT-NIRAF at baseline and with CCTA 12 months apart to demonstrate that:

1. NIRAF coronary artery signal level (patient, artery, lesion basis) is correlated with the severity of coronary artery disease. 2. NIRAF coronary artery signal level is a predictor of plaque progression on a per participant, per artery, or per lesion basis.

Arm 2: Participants undergoing coronary angiography for stable or acute coronary disease presentations and eligible for percutaneous coronary intervention (PCI) will be imaged with OCT-NIRAF following injection of LUMISIGHT. The primary objective is to assess the feasibility of intravascular detection and spatial localization of LUMISIGHT during routine coronary imaging.

Inclusion: 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: 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:; Patients who have taken an investigational drug within 14 days of enrollment; 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; Left main disease >= 50% stenosis in participants that do not have a functioning LAD bypass graft; 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 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; 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.

Arm 1:.

ClinicalTrials.gov NCT06374498