A Clinical Study of Fundus OCTA for the Identification of CMD

NCT05743140 | Recruiting

• 1 other identifier: ZHENG Bo
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Microvascular Disease

Keywords

coronary microvascular disease; CaIMR; OCT; OCTA; Fundus microcirculation

Outcome Measures

Primary Outcomes (1)

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

  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

Study Arms (1)

CMD group, Non-CMD group

CMD group: participants whose CaIMR shows ≥25U. Non-CMD group: participants whose CaIMR less than 25U.

Diagnostic Test: CaIMR

Interventions

CaIMR DIAGNOSTIC_TEST

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

Also known as: OCT, OCTA

CMD group, Non-CMD group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Department of Cardiology, Peking University First Hospital

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking university first hospital

Beijing, Beijing Municipality, 10034, China

RECRUITING

MeSH Terms

Conditions

Microvascular Angina

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Bo Zheng, Dr

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bo Zheng, Dr

CONTACT

13426046980; zhengbopatrick@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 24, 2023
• Study Start: March 1, 2023
• Primary Completion: December 12, 2025
• Study Completion: January 1, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)