A Clinical Study of Fundus OCTA for the Identification of CMD

Sponsor

Peking University First Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05743140

Collaborator

(none)

400

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Microvascular Disease	Diagnostic Test: CaIMR

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 Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

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

Anticipated Study Start Date :

Mar 3, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Diagnostic accuracy of fundus OCT and OCTA examinations for coronary microvascular disease [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.