OCT-NIRAF Imaging for Coronary Artery Disease

Overseen By Catriona Grant, MSN, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Renal insufficiency, Pregnancy, Myocardial infarction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment OCT-NIRAF for coronary artery disease?

Research shows that OCT-NIRAF imaging can identify high-risk features in coronary artery plaques, which are important for diagnosing vulnerable plaques that could lead to heart attacks. This imaging method combines detailed structural information from OCT with chemical insights from NIRAF, making it a promising tool for better understanding and managing coronary artery disease. ^{1 2 3 4 5}

Is OCT-NIRAF imaging safe for use in humans?

The long-term safety of OCT-NIRAF imaging in humans has been assessed in studies like the IBIS-4, which showed that intracoronary imaging using OCT is generally safe, with a low rate of complications and major adverse cardiac events over two years. ^{1 2 5 6 7}

How does OCT-NIRAF imaging differ from other treatments for coronary artery disease?

OCT-NIRAF imaging is unique because it combines optical coherence tomography (OCT) with near-infrared autofluorescence (NIRAF) to provide detailed images of coronary artery plaques, helping to identify high-risk features that could lead to heart attacks. This dual-modality approach offers more precise characterization of plaque vulnerability compared to OCT alone, which primarily focuses on plaque structure. ^{1 2 4 5 8}

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.

Research Team

Guillermo J Tearney, MD, PhD

Principal Investigator

Massachusetts General Hospital

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.

Exclusion Criteria

Pregnancy

Persons under the protection of justice, guardianship, or curatorship

Inability to perform intravascular imaging of a target artery

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Patients undergo coronary angiography and intravascular imaging including OCT-NIRAF and IVUS

1 day

1 visit (in-person)

Follow-up Imaging

Patients undergo follow-up coronary CTA to assess plaque progression

12 months

1 visit (in-person)

Follow-up

Standard-of-care cardiology follow-up and medical record review at 1 month, 6 months, and 1 year

12 months

3 visits (in-person)

Treatment Details

Interventions

• OCT-NIRAF

Trial Overview The 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

Group I: Patients with stable CAD or acute coronary syndromes undergoing invasive coronary angiography Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Histopathological correlation of near infrared autofluorescence in human cadaver coronary arteries. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Intracoronary near infrared autofluorescence signal calibration. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Intracoronary optical coherence tomography: Clinical and research applications and intravascular imaging software overview. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Clinical Characterization of Coronary Atherosclerosis With Dual-Modality OCT and Near-Infrared Autofluorescence Imaging. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Ex vivo catheter-based imaging of coronary atherosclerosis using multimodality OCT and NIRAF excited at 633 nm. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Optical Coherence Tomography-Guided Percutaneous Coronary Intervention for ST-Segment Elevation Myocardial Infarction: Rationale and Design of the ATLAS-OCT Study. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Long-term safety and feasibility of three-vessel multimodality intravascular imaging in patients with ST-elevation myocardial infarction: the IBIS-4 (integrated biomarker and imaging study) substudy. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Targeted Near-Infrared Fluorescence Imaging of Atherosclerosis: Clinical and Intracoronary Evaluation of Indocyanine Green. [2022]