OFDI Imaging for Coronary Artery Disease

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Kidney insufficiency, Pregnancy, Heart attack, others

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

Compensation: Varies

Number of Visits: 6

320 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.

How does OFDI imaging differ from other treatments for coronary artery disease?

OFDI imaging (Optical Frequency Domain Imaging) is unique because it provides high-resolution images of the coronary arteries, allowing for detailed visualization of plaque and vessel structure, which is not possible with other noninvasive imaging techniques like MRI or CT scans. This can help in better understanding the progression of coronary artery disease and tailoring treatment strategies. ^{1 2 3 4 5}

What is the purpose of this trial?

Atherosclerosis, a condition in which fatty deposits of plaque build up along the inner walls of arteries, is a condition that may increase the risk of having a heart attack. Previous studies have shown that the presence of a specific kind of plaque, known as vulnerable plaque, is often found in people who have had a heart attack. This study will use a new imaging technique called optical frequency domain imaging (OFDI) to examine the presence of vulnerable plaques in people with coronary artery disease.

Research Team

Guillermo Tearney, MD, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for people with coronary artery disease who are undergoing a procedure called PCTI. Women of childbearing age must test negative for pregnancy before joining. People can't join if they have kidney issues, recent heart attacks, complex heart lesions, severe vascular disease, congestive heart failure, previous bypass surgery or are in another study.

Inclusion Criteria

I am receiving treatment for blocked heart arteries.

I am a woman who can have children and I have a negative pregnancy test from the last week.

Exclusion Criteria

I have a condition affecting the main artery of my heart.

I have had heart bypass surgery.

My kidney function is reduced.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging and Angioplasty

Participants undergo baseline angiography, followed by randomization to IVUS and OFDI imaging procedures, and then angioplasty with stent placement.

1 day

1 visit (in-person)

Follow-up Imaging

Participants undergo repeat IVUS and OFDI procedures to evaluate changes in heart blood vessels and plaque.

1 day

1 visit (in-person)

Long-term Follow-up

Participants complete questionnaires about medication history and heart problems every six months for two years.

2 years

4 visits (in-person or virtual)

Treatment Details

Interventions

• OFDI imaging

Trial Overview The trial is testing a new imaging method called OFDI to spot vulnerable plaques in the arteries that could lead to heart attacks. It aims to see how well this technique works in identifying these risky plaques compared to current methods.

Participant Groups

Group I: OFDI imaging Experimental Treatment 1 Intervention

OFDI catheter advanced to the distal coronary artery

Group II: Intravenous Ultrasound Experimental Treatment 1 Intervention

Randomization to determine whether Intravenous Ultrasound will be conducted before or after OFDI imaging.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Current noninvasive imaging techniques for detection of coronary artery disease. [2019]

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

Coronary MR imaging: lumen and wall. [2009]

3. China pubmed.ncbi.nlm.nih.gov

Therapeutic modulation of the natural history of coronary atherosclerosis: lessons learned from serial imaging studies. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Current and future trends in multimodality imaging of coronary artery disease. [2015]

5. England pubmed.ncbi.nlm.nih.gov

Noninvasive evaluation of coronary artery disease: magnetic resonance imaging & multi-slice computed tomography. [2009]