Deep Learning of Retinal Photographs and Atherosclerotic Cardiovascular Disease

Sponsor
Yonsei University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04749927
Collaborator
(none)
2,400
1
108
22.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2400 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prediction of Incident Atherosclerotic Cardiovascular Disease From Retinal Photographs Via Deep Learning
    Actual Study Start Date :
    Oct 11, 2020
    Anticipated Primary Completion Date :
    Oct 10, 2029
    Anticipated Study Completion Date :
    Oct 10, 2029

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 79 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yonsei University College of Medicine Seoul Korea, Republic of 03722

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    • Principal Investigator: Sungha Park, Severance Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT04749927
    Other Study ID Numbers:
    • 4-2020-0951
    First Posted:
    Feb 11, 2021
    Last Update Posted:
    Feb 11, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 11, 2021