Study to Determine the Clinical Significance of Intravascular OCT-NIRAF

Enrolling by invitation · Not applicable

Conditions studied: Cardiovascular Diseases, Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT06374498

Run by

Massachusetts General Hospital

People needed

40

Starts

2024-07-08

Expected to finish

2028-04-30

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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