A Clinical Study of Fundus OCTA for the Identification of CMD
ConditionCoronary Microvascular Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPeking University First Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial population
Department of Cardiology, Peking University First Hospital
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
CaIMR
Diagnostic testInvestigators diagnose CMD with CaIMR. Investigators use OCT and OCTA to analyze the fundus microcirculation quantitatively.
Treatment groups
400 Participants
are divided into 1 treatment groupGroup A: CMD group, Non-CMD group1 intervention
Trial outcomes
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.
Time frame
2023.3-2024.5Sponsors and contacts
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Source ClinicalTrials.gov