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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University First Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 12, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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