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NCT Number: NCT05743140

A Clinical Study of Fundus OCTA for the Identification of CMD

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking university first hospital

Beijing, Beijing Municipality, 10034, China

Location status: Recruiting

Location contact

Bo Zheng, Dr

CONTACT

[email protected]

13426046980

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

CaIMR

Diagnostic Test

Investigators diagnose CMD with CaIMR. Investigators use OCT and OCTA to analyze the fundus microcirculation quantitatively.

Other names: OCT, OCTA

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bo Zheng, Dr

CONTACT

[email protected]

13426046980

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Feb 24, 2023
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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