Imaging for Cardiovascular Disease

Overseen By Arnold Nadel

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Ophthalmologic disease, Stroke, others

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

Compensation: Varies

Number of Visits: 1

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether changes in the tiny blood vessels in the eyes can indicate the severity of heart disease. It employs a special eye scan called Swept Source Optical Coherence Tomography Angiography (SS-OCTA) to assess these blood vessels and compares the findings to results from a common heart test. The trial seeks participants who have undergone a standard heart scan and do not have eye diseases such as glaucoma or macular degeneration. Individuals who have experienced a stroke or sudden vision loss are ineligible. Participants should be comfortable with an eye exam. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance heart disease diagnosis.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this imaging technique is safe?

Research has shown that Swept Source Optical Coherence Tomography Angiography (SS-OCTA) is a safe imaging tool. Studies have found that SS-OCTA is non-invasive, as it does not involve surgery or entering the body. By using light to capture detailed images of blood vessels, it reduces the risk of complications.

In one study involving 337 eyes, SS-OCTA was used without causing significant side effects, indicating it is well-tolerated by patients. Another study confirmed that optical coherence tomography (OCT) imaging, similar to SS-OCTA, is reliable and safe for examining blood vessels.

Overall, current research considers SS-OCTA safe. It provides a clear view of blood vessels without major risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Swept Source Optical Coherence Tomography Angiography (SS-OCTA) is unique because it offers a non-invasive way to visualize blood vessels with remarkable detail, unlike traditional methods like angiography that require contrast dye and radiation. Researchers are excited about SS-OCTA because it can provide high-resolution images of the cardiovascular system, potentially allowing for earlier and more accurate detection of vascular issues. This advanced imaging technique also reduces patient risk and discomfort by eliminating the need for invasive procedures.

What evidence suggests that this imaging technique is effective for cardiovascular disease?

Research shows that Swept Source Optical Coherence Tomography Angiography (SS-OCTA), which all participants in this trial will receive, clearly displays details about the blood vessels in the eye. Studies have found links between changes in these eye vessels and heart health. SS-OCTA provides sharp, detailed images that aid in understanding the condition of the heart and blood vessels. Previous research has shown it to be a reliable and consistent method for examining heart-related issues. Overall, SS-OCTA holds promise in connecting eye health to heart health through advanced imaging techniques. ^{1 3 6 7 8}

Who Is on the Research Team?

Rukhsana Mirza, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 who are being checked for heart disease and can undergo a clinical eye exam. They must be able to consent, not have any known eye diseases except for needing glasses or contacts, and should be getting standard carotid artery scans.

Inclusion Criteria

Able to participate in a clinical eye examination setting.

Subjects receiving standard of care carotid duplex ultrasounds.

Able to consent.

Exclusion Criteria

You have had a stroke or sudden loss of vision in the past.

Lack of capacity to provide informed consent.

You can't have an eye examination as required for the clinical trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging and Assessment

Participants undergo SS-OCTA, color fundus photography, and retinal exams to assess retinal vasculature and correlate with cardiovascular disease

2 hours

1 visit (in-person)

Follow-up

Participants are monitored for any changes in retinal vasculature and cardiovascular health

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Swept Source Optical Coherence Tomography Angiography

Trial Overview The study is testing if a special type of eye scan called SS-OCTA can show changes in the tiny blood vessels of the retina that match up with how severe someone's heart disease is, as seen on neck artery ultrasounds.

How Is the Trial Designed?

Group I: All Participants Experimental Treatment 1 Intervention

50 participants identified in the Northwestern Medicine Division of Vascular Surgery.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Citations

1. nature.com nature.com/articles/s41598-024-78587-w

Artificial intelligence-based prediction of ... The value of swept-source retinal optical coherence tomography–angiography (SS OCT-A) imaging is significantly enhanced by image analysis tools ...

2. researchgate.net researchgate.net/publication/393759365_Optical_coherence_tomography_angiography_quantitative_analysis_and_10-year_cardiovascular_disease_risk_in_the_general_population

Optical coherence tomography angiography quantitative ... PURPOSE The aim of our study was to analyze the association between different cardiovascular risk scores and swept-source optical coherence ...

3. mdpi.com mdpi.com/2306-5729/8/10/147

A Retinal Oct-Angiography and Cardiovascular STAtus ... Optical coherence tomography angiography (OCT-A), as a window into the state of the cardiovascular system, is a rapid, reliable, and reproducible imaging ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3295975/

The Role of Optical Coherence Tomography in Coronary ... OCT is an optical analog of intravascular ultrasound (IVUS) that can be used to examine the coronary arteries and has 10-fold higher resolution than IVUS.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2772930325000183

Efficacy and Safety of High-Frequency Optical Coherence ... In this multicenter, single-arm study, we evaluated the efficacy and safety of a novel imaging catheter and system called high-frequency optical coherence ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4113036/

Intracoronary Optical Coherence Tomography - PubMed Central OCT is a catheter-based invasive imaging system. Using light rather than ultrasound, OCT produces high-resolution in vivo images of coronary arteries and ...

7. tvst.arvojournals.org tvst.arvojournals.org/article.aspx?articleid=2810613

Swept-Source OCT Angiography-Derived Regional Normative ... Methods: This study included 337 eyes without significant fundus abnormalities or systemic conditions affecting blood flow. Swept-source optical coherence ...

8. nature.com nature.com/articles/s41598-021-95982-9

Phase stable swept-source optical coherence tomography ... Swept-source optical coherence tomography (SS-OCT) is an imaging tool capable of providing three-dimensional information of biological tissues ...