A Clinical Study of Fundus OCTA for the Identification of CMD

Coronary Microvascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05743140
• Other study ID #: ZHENG Bo
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: July 2023
• Source: Peking University First Hospital
• Contact: Bo Zheng, Dr
• Phone: 13426046980
• Email: zhengbopatrick[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Microvascular Disease
• Microvascular Angina

Intervention

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

Locations

Country	Name	City	State
China	Peking university first hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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