Single-center Retrospective Confirmatory Clinical study to Evaluate the Efficacy of Retinal-based Cardiovascular Risk Assessment Software as Medical Device (SaMD) DrNoon for CVD
- Conditions
- Diseases of the circulatory system
- Registration Number
- KCT0007047
- Lead Sponsor
- Medi Whale
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1106
1. Patients who have been enrolled in the CMERC-HI study (Nov.2013 ~ Jun.2018)
2. Patients who have been followed up for 5 years and more or until 31.Dec.2021, or patients who experienced cardiovascular events
3. Age 20 ~ 80
1. Cohort of heart failure or cardiac infarction of the CMERC-HI study
2. Patients without any retinal photographs
3. Patients without any CT data of coronary calcification
4. Patients without any Carotid Ultrasound data
5. Patients without any pulse wave velocity(PWV) examination
6. Patients with missing value at least one of these factors; age, sex, smoking history and past medical history of hypertension or DM or hyperlipidemia
7. Cases have difficulty for analysis with DrNoon for CVD: low quality of retinal photographs including turbidity or artefact
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hazard ratio trends calculated for moderate and high risk groups based on low risk groups with retinal photographs
- Secondary Outcome Measures
Name Time Method Hazard ratio for moderate or high risk groups compared with the low risk groups: Coronary artery calcium score, Carotid intima-media thickness, Pulse wave velocity;Compare the performance between three risk groups with retinal photographs and three risk groups with coronary artery calcium score