Using deep learning to analyze retinal photographs for cardiovascular disease prediction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to validate a deep learning algorithm that predicts cardiovascular disease risk based on fundus photographs. Participants will have their retinal images taken to assess various cardiovascular conditions, including myocardial infarction and heart failure. The study will follow participants for five years to track major cardiovascular events and verify the algorithm's predictive capabilities. Fundus photographs will be collected twice in the first year and again two years later to enhance the data set for analysis.

Why it matters

Who can join: the full rules

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

Where it's running

• Yonsei University College of Medicine
  Seoul, South Korea Recruiting

Study contacts

• Principal investigator: Sungha Park — Severance Hospital
• Study coordinator: Sungha Park
• Email: shpark0530@yuhs.ac
• Phone: +82-2228-8460

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.