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Deep Learning of Retinal Photographs and Atherosclerotic Cardiovascular Disease

Prediction of Incident Atherosclerotic Cardiovascular Disease From Retinal Photographs Via Deep Learning

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04749927
Enrollment
2400
Registered
2021-02-11
Start date
2020-10-11
Completion date
2029-10-10
Last updated
2021-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease

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.

Interventions

None listed

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Major adverse cardiovascular disease4 yearsComposite of myocardial infarction, stroke, coronary revascularization including percutaneous coronary intervention and coronary bypass graft, and hospitalization for heart failure

Countries

South Korea

Contacts

Primary ContactSungha Park
shpark0530@yuhs.ac+82-2228-8460

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026