A Clinical Study of Fundus OCTA for the Identification of CMD

August 7, 2025 updated by: ZHENG Bo, Peking University First Hospital

A Clinical Study of Fundus Optical Coherence Tomography Angiography for the Identification of Coronary Microvascular Diseases

Coronary microvascular dysfunction (CMD) carries an increased risk of adverse cardiovascular clinical outcomes. The association between fundus microcirculation changes and coronary microcirculation is not well understood. Optical coherence tomography (OCT) and optical coherence tomography angiography (OCTA) is a new type of optical diagnostic imaging technology for non-invasive detection, which can perform multi-dimensional quantitative assessment of fundus microcirculation. In this study, investigators intend to use the coronary angiography-derived index of microvascular resistance (caIMR) to screen patients with CMD, explore the relationship between relevant parameters based on OCT and OCTA measurements and caIMR, and evaluate the feasibility and clinical value of non-invasive identification of CMD through fundus OCT and OCTA.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Coronary microvascular dysfunction (CMD) is defined as the clinical syndrome of angina and electrocardiographic ischemic changes in the absence of obstructive coronary artery disease. CMD carries an increased risk of adverse cardiovascular clinical outcomes. Assessment of CMD is performed with different diagnostic modalities, including nuclear myocardial scintigraphy, cardiac magnetic resonance, doppler echocardiography, and coronary microcirculation resistance index techniques. However, current examination techniques have limitations such as radiation risk, high cost, and time-consuming, so they cannot be widely screened in the population. Previous studies have shown that fundus vascular changes were strongly associated with cardiovascular events, but the correlation between fundus microcirculation changes and coronary microcirculation is not well understood. Optical coherence tomography (OCT) and optical coherence tomography angiography (OCTA) is a new type of optical diagnostic imaging technology for non-invasive detection, which use infrared light projection onto fundus tissue to achieve real-time tomographic section imaging, which can perform multi-dimensional quantitative assessment of fundus microcirculation. In this study, investigators intend to use the coronary angiography-derived index of microvascular resistance (caIMR) to screen patients with CMD, explore the relationship between relevant parameters based on OCT and OCTA measurements and caIMR, and evaluate the feasibility and clinical value of non-invasive identification of CMD through fundus OCT and OCTA.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 10034
        • Recruiting
        • Peking University First Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Department of Cardiology, Peking University First Hospital

Description

Inclusion Criteria:

  1. Patients who underwent coronary angiography in the Department of Cardiology, Peking University First Hospital;
  2. Complete baseline clinical information;
  3. Subject who have coronary angiography results, which shows coronary stenosis < 50%;
  4. Older than 18 years;
  5. Subjects who have signed informed consent.

Exclusion Criteria:

  1. Present serious fundus disease
  2. Severe cataract and other ophthalmic diseases, which affect imaging quality;
  3. Target coronary vessels provide collateral circulation for chronic complete occlusive lesions;
  4. The target coronary angiography agent is poorly filled, overlapped, or severely distorted, and cannot fully expose the location of the lesion;
  5. Coronary angiography images are of poor quality and cannot be identified;
  6. Active bleeding state;
  7. Severe renal insufficiency, contrast agent allergy, and unable to perform coronary angiography.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CMD group, Non-CMD group
CMD group: participants whose CaIMR shows ≥25U. Non-CMD group: participants whose CaIMR less than 25U.
Diagnostic test: CaIMR
Investigators diagnose CMD with CaIMR. Investigators use OCT and OCTA to analyze the fundus microcirculation quantitatively.
Other Names:
  • OCT
  • OCTA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of fundus OCT and OCTA examinations for coronary microvascular disease
Time Frame: 2023.3-2024.5
Investigators intend to use these indicators to assess the diagnostic accuracy of fundus OCT and OCTA for CMD: area under the receiver operating characteristic curve (AUROC), sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio.
2023.3-2024.5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Investigators

  • Principal Investigator: Bo Zheng, Dr, Peking University First Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

December 12, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

February 7, 2023

First Submitted That Met QC Criteria

February 14, 2023

First Posted (Actual)

February 24, 2023

Study Record Updates

Last Update Posted (Actual)

August 12, 2025

Last Update Submitted That Met QC Criteria

August 7, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZHENG Bo

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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