Status:

RECRUITING

Deep Learning of Retinal Photographs and Atherosclerotic Cardiovascular Disease

Lead Sponsor:

Yonsei University

Conditions:

Cardiovascular Disease

Eligibility:

All Genders

20-79 years

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 ar...

Eligibility Criteria

Inclusion

  • Myocardial infarction (Patients diagnosed with myocardial infarction within 5 years and confirmed significant coronary artery stenosis by cardiovascular angiography)
  • Heart failure with reduced EF (\<40% of LVEF on echocardiography or magnetic resonance imaging)
  • 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))
  • 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)
  • 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)
  • High risk dyslipidemia (LDL-cholesterol \>190 mg/dL or \> 160 mg/dL inspire of use of moderate or high intensity statin)
  • Diabetes (Type 2 diabetes with more than 5 years of diagnosis or type 1 diabetes with more than 10 years of diagnosis)
  • 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

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

Key Trial Info

Start Date :

October 11 2020

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

October 10 2029

Estimated Enrollment :

2400 Patients enrolled

Trial Details

Trial ID

NCT04749927

Start Date

October 11 2020

End Date

October 10 2029

Last Update

February 11 2021

Active Locations (1)

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1

Yonsei University College of Medicine

Seoul, South Korea, 03722