Cardiovascular DiseaseNCT04749927
Deep Learning of Retinal Photographs and Atherosclerotic Cardiovascular Disease
An observational study of Cardiovascular Disease, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- How many people
- 2,400 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Oct 2020to 10 Oct 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Visiting outpatient clinic in the tertiary hospital
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University College of Medicine
Seoul, 03722
Sungha Park, +82-2228-8460, shpark0530@yuhs.ac
About this study
Official title: Prediction of Incident Atherosclerotic Cardiovascular Disease From Retinal Photographs Via Deep Learning
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.
- Conditions
- Cardiovascular Disease
- Medical subject headings
- Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular disease
Composite of myocardial infarction, stroke, coronary revascularization including percutaneous coronary intervention and coronary bypass graft, and hospitalization for heart failure
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start11 Oct 2020
- Primary completion10 Oct 2029 (estimated)
- Study completion10 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sungha Park, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749927
- Sponsor's protocol ID
- 4-2020-0951
- Status last verified
- Feb 2021
- First submitted
- 8 Feb 2021
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Incident Atherosclerotic Cardiovascular Disease From Retinal Photographs Via Deep Learning
- ClinicalTrials.gov ID
- NCT04749927
- Acronym / sponsor ID
- 4-2020-0951
- Conditions
- Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 11 Oct 2020 (actual)
- Primary completion
- 10 Oct 2029 (estimated)
- Study completion
- 10 Oct 2029 (estimated)
- First posted
- 11 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Visiting outpatient clinic in the tertiary hospital
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major adverse cardiovascular disease
Time frame: 4 years
Composite of myocardial infarction, stroke, coronary revascularization including percutaneous coronary intervention and coronary bypass graft, and hospitalization for heart failure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sungha Park principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sungha Park (+82-2228-8460, shpark0530@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular disease (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.