Deep Learning of Retinal Photographs and Atherosclerotic Cardiovascular Disease

Recruiting

• Conditions: Cardiovascular Disease

• Registration Number: NCT04749927
• Lead Sponsor: Yonsei University

Brief Summary

The research team has developed a deep learning algorithm that predicts anthropometric factors from fundus photographs and an algorithm that predicts cardiovascular disease risk. Fundus photographs are taken for various cardiovascular diseases (myocardial infarction, heart failure, hypertension with target organ damage, high-risk dyslipidemia, diabetic patients, and low-risk hypertension patients), and a deep learning algorithm for predicting developed anthropometric factors will be validated. Fundus photographs will also be taken twice in the first year, and additional fundus photographs will be taken two years later. Major cardiovascular events will be followed up for 5 years to verify the deep learning algorithm predicting cardiovascular disease risk prospectively.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-11
• Status Verified: 2021-02
• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-02-08
• Last Update Submitted: 2021-02-08
• Study First Posted: 2021-02-11
• Last Update Posted: 2021-02-11
• Primary Completion: 2029-10-10
• Study Completion: 2029-10-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2400

Inclusion Criteria

1. Myocardial infarction (Patients diagnosed with myocardial infarction within 5 years and confirmed significant coronary artery stenosis by cardiovascular angiography)
2. Heart failure with reduced EF (<40% of LVEF on echocardiography or magnetic resonance imaging)
3. Heart failure with preserved EF (≥40% of LVEF on echocardiography and NT-proBNP ≥200 pg/mL and LAVI ≥ 34 ml/m2 or LVMI ≥115 g/m2 (men) or LVMI ≥95 g/m2 (women))
4. High risk subclinical atherosclerosis (no symptom and ≥50% stenosis of coronary artery on coronary angio CT or asymptomatic PAOD or cerebral aneurysm or ≥50% stenosis of cerebral artery or ABI <0.9 or ≥2mm of atherosclerotic plaque or hypoechogenic plaque on carotid ultrasound)
5. Hypertension with target organ damage (proteinuria [urine albumin/creatinine ratio ≥ 30 mg/g or protein/creatinine ratio ≥ 150 mg/g or 24 hour urine albumin ≥30mg/day or 24 hour urine protein ≥ 150mg/day] or LV hypertrophy [on EKG or echocardiography] or cfPWV > 10 m/sec or baPWV > 1800 cm/sec or eGFR < 60 ml/min/1.72 m2 or atherosclerotic cardiovascular disease or white matter hyperintensity on brain MRI)
6. High risk dyslipidemia (LDL-cholesterol >190 mg/dL or > 160 mg/dL inspire of use of moderate or high intensity statin)
7. Diabetes (Type 2 diabetes with more than 5 years of diagnosis or type 1 diabetes with more than 10 years of diagnosis)
8. Low risk (Hypertension that does not meet the above criteria and is controlled by 3 drugs or less 2) Dyslipidemia that does not meet the above criteria and is controlled below the target LDL)

Exclusion Criteria

1. Serious eye diseases that make it impossible to take adequate quality fundus photography
2. If the subject cannot read and sign the consent form in person

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major adverse cardiovascular disease	4 years	Composite of myocardial infarction, stroke, coronary revascularization including percutaneous coronary intervention and coronary bypass graft, and hospitalization for heart failure

Trial Locations

Locations (1)

Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of