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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a special imaging technique called OCT-NIRAF (Optical Coherence Tomography with Near-Infrared Autofluorescence) can enhance the understanding of coronary artery disease. The researchers aim to determine if OCT-NIRAF signals can indicate the severity of artery disease and predict the progression of artery plaque. Suitable candidates for this trial include individuals with stable or acute coronary artery conditions scheduled for coronary angiography, a procedure that examines blood vessels. As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research that could improve future heart disease diagnostics.

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 prior data suggests that OCT-NIRAF imaging is safe for coronary artery disease patients?

Studies have shown that OCT-NIRAF, a new imaging technique, is safe for people. One study found that this method effectively examines the coronary arteries, which supply blood to the heart. The study reported no harmful effects from using OCT-NIRAF.

Research indicates that the light used in this imaging is safe. More recent studies have also shown that this technology does not cause harm when used in procedures similar to those in the trial.

Overall, the safety record of OCT-NIRAF in past studies suggests it is well-tolerated in humans. This provides a reassuring picture for those considering participation in a trial using this technology. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about OCT-NIRAF imaging for coronary artery disease because it offers a new way to visualize plaque in the coronary arteries. Unlike traditional methods like angiography or intravascular ultrasound, OCT-NIRAF combines Optical Coherence Tomography (OCT) with Near-Infrared Autofluorescence (NIRAF) to provide more detailed information about the biological composition of plaques. This could help doctors better identify high-risk plaques that might lead to heart attacks. This innovative approach could lead to more personalized and effective treatments for patients with coronary artery disease.

What evidence suggests that OCT-NIRAF is effective for coronary artery disease?

Research has shown that OCT-NIRAF imaging, which participants in this trial will undergo, is a promising tool for understanding heart artery disease. Studies have found it safe and effective for examining coronary arteries. This technology combines optical coherence tomography (OCT) and near-infrared autofluorescence (NIRAF) to identify areas in the arteries at risk for plaque buildup. Early findings suggest these areas often relate to more severe disease and bleeding within the artery walls. This makes OCT-NIRAF a potential method for predicting disease progression over time. Although more research is needed, the technology appears promising for providing detailed insights into heart health. ^{1 3 4 5 6}

Who Is on the Research Team?

Guillermo J Tearney, MD, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Participants 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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5010789/

First-In-Human Dual-Modality OCT and Near-Infrared ... We present the first clinical imaging of human coronary arteries in vivo using a multimodality OCT and near-infrared autofluorescence (NIRAF) ...

2. nature.com nature.com/articles/s41598-018-32951-9

Comprehensive intravascular imaging of atherosclerotic ... demonstrated that IV-OCT/NIRAF is a safe and effective intracoronary imaging method in human patients by showing that the autofluorescence ...

3. opg.optica.org opg.optica.org/boe/fulltext.cfm?uri=boe-6-4-1363

Ex vivo catheter-based imaging of coronary atherosclerosis ... In the next section, we describe the results from catheter-based OCT-NIRAF imaging of human coronary arteries ex vivo. 3.2 OCT-NIRAF catheter based ex vivo ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1936878X21003430

Multimodality Intravascular Imaging of High-Risk Coronary ... This review examines these emerging hybrid intracoronary imaging techniques and discusses their strengths, limitations, and potential for clinical translation.

5. ahajournals.org ahajournals.org/doi/10.1161/ATVBAHA.120.315612

Near-Infrared Autofluorescence in Atherosclerosis ... Near-infrared autofluorescence (NIRAF) of atherosclerosis associates with intraplaque hemorrhage and is detectable in living patients with coronary artery ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6419760/

Intravascular NIRF Molecular Imaging Approaches in ... Here we present recent progress in intravascular near-infrared fluorescence (NIRF) molecular imaging, including the evolution from standalone NIRF systems.