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Single-center Retrospective Confirmatory Clinical study to Evaluate the Efficacy of Retinal-based Cardiovascular Risk Assessment Software as Medical Device (SaMD) DrNoon for CVD

Single-center Retrospective Confirmatory Clinical study to Evaluate the Efficacy of Retinal-based Cardiovascular Risk Assessment Software as Medical Device (SaMD) DrNoon for CVD

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0007047
Enrollment
1106
Registered
2022-03-04
Start date
2022-03-22
Completion date
Unknown
Last updated
2022-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Medi Whale
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Hazard ratio trends calculated for moderate and high risk groups based on low risk groups with retinal photographs

Secondary

MeasureTime frame
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

Countries

Korea, Republic of

Contacts

Public ContactKevin Taegeun Lee

Medi Whale

kevin@medi-whale.com+82-2-2179-8780

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026