Deep Learning of Retinal Photographs and Atherosclerotic Cardiovascular Disease

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04749927
• Other study ID #: 4-2020-0951
• Status: Recruiting
• Start date: October 11, 2020
• Est. completion date: October 10, 2029

Study information

• Verified date: February 2021
• Source: Yonsei University
• Contact: Sungha Park
• Phone: +82-2228-8460
• Email: shpark0530[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2400
• Est. completion date: October 10, 2029
• Est. primary completion date: October 10, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Disease
• Cardiovascular Diseases

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiovascular disease	Composite of myocardial infarction, stroke, coronary revascularization including percutaneous coronary intervention and coronary bypass graft, and hospitalization for heart failure	4 years