OCT-NIRAF Imaging for Coronary Artery Disease

Recruiting in Palo Alto (17 mi)

Overseen byGuillermo J Tearney, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?

Patients 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 patient, per artery, or per lesion basis.

Eligibility Criteria

This trial is for individuals undergoing coronary angiography due to stable or acute coronary disease and who are candidates for a procedure called PCI. Specific details about who can join or reasons why someone might not be eligible are not provided.

Inclusion Criteria

Patient must be able to give informed consent

I am eligible for a brain radiation procedure.

I am over 18 years old.

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Exclusion Criteria

Pregnancy

Persons under the protection of justice, guardianship, or curatorship

Inability to perform intravascular imaging of a target artery

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Treatment Details

Interventions

OCT-NIRAF (Imaging Device)

Trial OverviewThe study is testing OCT-NIRAF imaging during heart procedures to see if the level of NIRAF signal in arteries correlates with how severe the artery disease is, and if it can predict worsening of the condition over time.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Patients with stable CAD or acute coronary syndromes undergoing invasive coronary angiographyExperimental Treatment1 Intervention

Patients referred to the Cardiology Division of the Massachusetts General Hospital, undergoing coronary angiography for stable or acute coronary disease and eligible for percutaneous coronary intervention (PCI) will be eligible for the study.