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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to use a new imaging technique called optical frequency domain imaging (OFDI) to identify dangerous plaques in people with coronary artery disease. These plaques can increase the risk of a heart attack. The study will compare OFDI with intravenous ultrasound to evaluate how well each method detects these risky plaques. Suitable candidates for this trial include those undergoing treatment for coronary artery disease, but they should not have severe kidney problems or recent heart attacks.

As an unphased trial, this study offers a unique opportunity to advance imaging techniques that could improve heart health 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 this imaging technique is safe for examining coronary artery disease?

Previous studies have shown that optical frequency domain imaging (OFDI) is as safe as other similar imaging techniques. Patients who underwent OFDI experienced results similar to those who had intravascular ultrasound (IVUS), another common method used in heart procedures. OFDI did not present more risks or issues than IVUS.

For example, one study found that OFDI was just as effective as IVUS in helping doctors open blocked arteries. A review of several studies concluded that OFDI is similar to IVUS in terms of safety and effectiveness. These findings suggest that OFDI is well-tolerated by patients and does not cause more problems than other methods.

In summary, OFDI has been shown to be safe and comparable to other standard imaging techniques used in heart care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about OFDI imaging for coronary artery disease because it offers a high-resolution view of the coronary arteries, surpassing the level of detail provided by traditional imaging techniques like angiography. This advanced imaging method uses light to capture detailed images of artery walls, potentially allowing for earlier detection and better characterization of plaques. Additionally, the trial includes Intravenous Ultrasound, which is being explored for its ability to complement OFDI imaging by providing insights into artery structure and function, enhancing the overall understanding of coronary artery conditions. Together, these techniques could lead to more precise and personalized treatment strategies for patients with coronary artery disease.

What evidence suggests that OFDI imaging is effective for detecting vulnerable plaques in coronary artery disease?

This trial will compare optical frequency domain imaging (OFDI) with intravenous ultrasound (IVUS) for evaluating heart artery conditions. Studies have shown that OFDI effectively assesses heart artery conditions and performs as well as IVUS in guiding procedures like PCI, a heart procedure to open blocked arteries, with similar results after 12 months. OFDI is particularly useful for checking the proper placement and function of stents (small tubes) in arteries. Additionally, OFDI provides detailed images of heart arteries, making it valuable for identifying issues like vulnerable plaques, which can lead to heart attacks. These findings suggest that OFDI is a reliable method for examining heart artery disease. ^{1 2 6 7 8}

Who Is on the Research Team?

Guillermo Tearney, MD, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.120.009314

Comparison Between Optical Frequency Domain Imaging ... OFDI-guided PCI was not inferior to IVUS-guided PCI in terms of in-segment minimum lumen area at 8 months. Although a small sample size was ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5837511/

Optical frequency domain imaging vs. intravascular ... The 12-month clinical outcome in patients undergoing OFDI-guided PCI was non-inferior to that of patients undergoing IVUS-guided PCI. Both OFDI-guided and IVUS- ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01873222

OPtical Frequency Domain Imaging Versus INtravascular ... (UMIN000010580) The aim of this study is to evaluate how Optical frequency domain imaging (OFDI) or Intravascular Ultrasound (IVUS) imaging technology influence ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2903715/

Coronary optical frequency domain imaging (OFDI) for in ... The present study demonstrates that OFDI is a highly promising tool for accurate evaluation of coronary stent strut coverage, as supported by a ...

5. jacc.org jacc.org/doi/10.1016/j.jcmg.2008.06.007

Three-Dimensional Coronary Artery Microscopy by ... Our results demonstrate that OFDI is a viable method for imaging the microstructure of long coronary segments in patients.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40351289/

Optical frequency domain imaging versus intravascular ... This meta-analysis of RCTs suggests that OFDI is comparable to IVUS in efficacy and safety for guiding PCI, with no significant differences in clinical ...

7. eurointervention.pcronline.com eurointervention.pcronline.com/article/safety-and-feasibility-of-frequency-domain-optical-coherence-tomography-to-guide-decision-making-in-percutaneous-coronary-intervention

Safety and feasibility of frequency domain optical ... This registry study evaluated the safety and feasibility of using frequency domain optical coherence tomography (FD-OCT) during coronary interventions.

8. jacc.org jacc.org/doi/10.1016/j.jcmg.2017.06.021

Optical Frequency Domain Imaging Versus Intravascular ... A multicenter, prospective, randomized, noninferiority trial comparing optical frequency domain imaging (OFDI)-guided PCI with IVUS-guided PCI.