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A cardiovascular disease risk assessment system using fundus photographs and deep learning algorithm: reliability, validity, and clinical value

A cardiovascular disease risk assessment system using fundus photographs and deep learning algorithm: reliability, validity, and clinical value

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300076069
Enrollment
Unknown
Registered
2023-09-23
Start date
2023-09-23
Completion date
Unknown
Last updated
2023-09-26

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

Conditions

cardiovascular diseases

Interventions

sub-study 1 (All participants in sub-study 1 will take four times of bilateral non-mydriatic fundus photographs, including two times using traditional fundus camera (Canon CR-2 AF) and two times using
sub-study 4 (All participants in sub-study 4 will take repeated bilateral non-mydriatic fundus photographs and blood press measurement hourly from 8:00 am to 8:00 pm for three days. Basic information
sub-study 5 (Bilateral non-mydriatic fundus photography as well as blood pressure measurement will be scheduled for these participants before and after initiating anti-hypertension therapy. Fourteen f

Sponsors

Peking University Clinical Research Institute
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 74 Years

Inclusion criteria

Inclusion criteria: Sub-study 1 & 4: 1. Men and women aged 20–74 years old. 2. No history of stroke or coronary heart disease 3. Signed informed consent. Sub-study 5: 1. Men and women aged 20–74 years old. 2. No history of stroke or coronary heart disease 3. Newly diagnosed hypertensive patients and is going to initiate antihypertensive drug treatment. 4. Signed informed consent.

Exclusion criteria

Exclusion criteria: Sub-study 1 & 5: 1. Patients with critical illness, such as malignant tumour or end-stage renal disease; 2. Patients with mental disease and cannot complete the examinations in the study; 3. Cannot bear the flashing light of fundus camera; 4. History of retinal laser therapy, cataract, blindness, or congenital miosis. Sub-study 4: 1. Patients with critical illness, such as malignant tumour or end-stage renal disease; 2. Patients with mental disease and cannot complete the examinations in the study; 3. Cannot bear the flashing light of fundus camera; 4. History of retinal laser therapy, cataract, blindness, or congenital miosis. 5. Cannot attending the three-day examinations.

Design outcomes

Primary

MeasureTime frame
ICC(same camera);C-index;correlation coefficient;ICC;

Secondary

MeasureTime frame
Mean difference (same camera);coefficient of correlation (same camera);Mean difference (different camera);coefficient of correlation (different camera);ICC;

Countries

China

Contacts

Public ContactYangfeng Wu

Peking University Clinical Research Institute

wuyf@bjmu.edu.cn+86 10 8280 5831

Outcome results

None listed

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