Status:
UNKNOWN
Development of CV Risk Prediction Tools Based on AI and Fundus Imaging Technology Study (PERFECT)
Lead Sponsor:
China National Center for Cardiovascular Diseases
Collaborating Sponsors:
Beijing Tongren Hospital
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Brief 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.
Detailed 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 c...
Eligibility Criteria
Inclusion
- 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:
- Men aged ≥ 60 years old, or women aged ≥ 65 years old;
- Diabetes;
- Total cholesterol\>5.2 mmol/L, or LDL-C\>3.4 mmol/L, or HDL-C\<1.0 mmol/L;
- Currently smoking, defined as daily smoking lasting for 1 year or more.
Exclusion
- Participants unable to provide fundus imaging data required for the study due to the following reasons:
- Permanent blindness, blurred vision, flying mosquito disease, or refractive medium opacity seriously affecting fundus examination, such as severe cataracts, vitreous hemorrhage, etc.
- Macular edema, severe nonproliferative retinopathy in diabetes, proliferative vitreoretinopathy, radiation ophthalmopathy or retinal vein occlusion
- Eyeball enucleation, eye deformities, etc.
- Previous retinal laser therapy, injection therapy for any eye, or history of retinal surgery
- Photosensitivity, or taking medication that can cause photosensitivity, or currently undergoing photodynamic therapy
- Unable to cooperate with examination for collection of fundus imaging data
- 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
Key Trial Info
Start Date :
December 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
1072 Patients enrolled
Trial Details
Trial ID
NCT06181552
Start Date
December 1 2023
End Date
June 1 2025
Last Update
December 26 2023
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