Clinical trial NCT04749927: Deep Learning of Retinal Photographs and Atherosclerotic Cardiovascular Disease
Official title: Prediction of Incident Atherosclerotic Cardiovascular Disease From Retinal Photographs Via Deep Learning
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 2400
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Visiting outpatient clinic in the tertiary hospital

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.


Eligibility criteria: 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

Primary outcomes:
measure: Major adverse cardiovascular disease
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine
Study officials:
affiliation: Severance Hospital
name: Sungha Park
role: PRINCIPAL_INVESTIGATOR
References: