Development of CV Risk Prediction Tools Based on AI and Fundus Imaging Technology Study (PERFECT)

Cardiovascular Diseases Clinical Trial

— PERFECT  

Official title:

Development of Cardiovascular Risk Prediction Tools Based on Artificial Intelligence and Fundus Imaging Technology Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06181552
• Other study ID #: 2023-GSP-GG-10
• Status: Not yet recruiting
• Start date: December 2023
• Est. completion date: June 2025

Study information

• Verified date: December 2023
• Source: China National Center for Cardiovascular Diseases
• Contact: Jing Li, PhD, MD
• Phone: +86 60866077
• Email: jing.li[@]fwoxford.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to develop a cardiovascular disease (CVD) screening tool and cardiovascular risk prediction tool based on fundus imaging data with the method of artificial intelligence.

Description:

This study will establish a cohort of individuals including patients with CVD and participants with high CVD risk, and all the study participants will be follow-up for 1 year. By collecting baseline clinical data, fundus imaging data, and CVD events during the follow up, this study aims to distinguish CVD status based on the fundus imaging data, and explore the association between fundus imaging data and occurence of CVD during the follow up. By using machine learning approach, this study aims to construct a CVD screening tool and CVD prediction tool based on fundus imaging data.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1072
• Est. completion date: June 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Three types of participants will be included, which are:

• Participants with established coronary heart disease, including previously diagnosed myocardial infarction, previous treatment with coronary intervention or coronary artery bypass grafting, coronary artery stenosis =50%, or chest pain with objective evidence of myocardial ischemia (myocardial ischemia indicated by stress electrocardiogram or stress imaging)

• Participants with established stroke.

• Participants without coronary heart disease or stroke, but are at high risk for CVD, defined as meeting at least two of the following:

1. Men aged = 60 years old, or women aged = 65 years old;

2. Diabetes;

3. Total cholesterol>5.2 mmol/L, or LDL-C>3.4 mmol/L, or HDL-C<1.0 mmol/L;

4. Currently smoking, defined as daily smoking lasting for 1 year or more.

Exclusion Criteria:

• Participants unable to provide fundus imaging data required for the study due to the following reasons:

1. Permanent blindness, blurred vision, flying mosquito disease, or refractive medium opacity seriously affecting fundus examination, such as severe cataracts, vitreous hemorrhage, etc.

2. Macular edema, severe nonproliferative retinopathy in diabetes, proliferative vitreoretinopathy, radiation ophthalmopathy or retinal vein occlusion

3. Eyeball enucleation, eye deformities, etc.

4. Previous retinal laser therapy, injection therapy for any eye, or history of retinal surgery

5. Photosensitivity, or taking medication that can cause photosensitivity, or currently undergoing photodynamic therapy

6. Unable to cooperate with examination for collection of fundus imaging data

7. Other situations that the participants fail to provide fundus imaging data required for the study

• Suffering from other serious diseases with an expected survival period of less than one year, such as advanced malignant tumors

• Unable to adhere to follow-up

• Other conditions which the researchers consider inappropriate for participants to enroll in the study

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Diagnostic Test:
• fundus photograpgy
All the participants will undergo fundus photography.
• optical coherence tomography
All the participants will undergo OCT examination.
• optical coherence tomography angiography
All the participants will undergo OCT-A examination.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases	Beijing Tongren Hospital

References & Publications (1)

Poplin R, Varadarajan AV, Blumer K, Liu Y, McConnell MV, Corrado GS, Peng L, Webster DR. Prediction of cardiovascular risk factors from retinal fundus photographs via deep learning. Nat Biomed Eng. 2018 Mar;2(3):158-164. doi: 10.1038/s41551-018-0195-0. Ep — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of ASCVD at baseline	Whether participants have established ASCVD at baseline	At enrollment
Primary	Major cardiovascular events	a composite of myocardial infarction, coronary or non coronary revascularization surgery, hospitalization or emergency treatment due to new-onset or worsening heart failure, stroke or cardiovascular death	during the 1 year follow-up