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Enrolling By Invitation
NCT06374498
Study to Determine the Clinical Significance of Intravascular OCT-NIRAF
Conditions: Cardiovascular Diseases, Coronary Artery Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 70
Sponsor: Massachusetts General Hospital
Location: Massachusetts General Hospital Boston Massachusetts
Summary
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.
Eligibility Criteria
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\
Source: ClinicalTrials.gov (NCT06374498). StuddyBuddy aggregates publicly available trial information.