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

Not yet recruiting

• Conditions: Cardiovascular Diseases
• Interventions: Diagnostic Test: fundus photograpgy; Diagnostic Test: optical coherence tomography; Diagnostic Test: optical coherence tomography angiography

• Registration Number: NCT06181552
• Lead Sponsor: China National Center for Cardiovascular Diseases

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 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.

Study Timeline

• Study First Submitted: 2023-11-09
• Status Verified: 2023-12
• Study Start: 2023-12
• Study First Submitted QC: 2023-12-20
• Last Update Submitted: 2023-12-20
• Study First Posted: 2023-12-26
• Last Update Posted: 2023-12-26
• Primary Completion: 2025-03
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1072

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with high CVD risk	fundus photograpgy	Participants without CVD, but 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.
Participants with high CVD risk	optical coherence tomography	Participants without CVD, but 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.
Participants with CVD	optical coherence tomography	Meeting any of the following: 1. 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 (indicated by stress electrocardiogram or stress imaging) 2. Stroke
Participants with CVD	optical coherence tomography angiography	Meeting any of the following: 1. 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 (indicated by stress electrocardiogram or stress imaging) 2. Stroke
Participants with CVD	fundus photograpgy	Meeting any of the following: 1. 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 (indicated by stress electrocardiogram or stress imaging) 2. Stroke
Participants with high CVD risk	optical coherence tomography angiography	Participants without CVD, but 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.

Primary Outcome Measures

Name	Time	Method
Diagnosis of ASCVD at baseline	At enrollment	Whether participants have established ASCVD at baseline
Major cardiovascular events	during the 1 year follow-up	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