JARVISDHL Screening Tools
1 other identifier
observational
2,000
1 country
1
Brief Summary
The main purpose of this study is to pioneer an easy risk stratification tools, which is developed using novel artificial intelligence (AI) algorithms, that will be able to detect common and fatal heart diseases easily simply through a picture of the back of the eye, the retina. The retinal images will be analysed using a computer application with the risk stratification tool to predict health outcome of individual. The study also aims to correlate between clinical characteristics, lifestyle (eg. exercise, sleep, erectile dysfunction) and diet to retinal and coronary vasculature and clinical outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2022
CompletedFirst Posted
Study publicly available on registry
November 23, 2022
CompletedStudy Start
First participant enrolled
January 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
ExpectedNovember 23, 2022
September 1, 2022
1.4 years
September 13, 2022
November 22, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
AI model and retinal imaging
This study will also expand the potential for AI models and retinal imaging as tools to identify systemic micro and macrovascular diseases such as hypertension, stroke and provide an easily available, risk-free tool for physicians to readily evaluate the state of the body's vessels.
Through study completion, an average of 2 years
Secondary Outcomes (4)
cross sectional performance of Cardiovascular risk stratification tool
Through study completion, an average of 2 years
longitudinal major cardiovascular event rate in subjects identified as high risk
Through study completion, an average of 2 years
major cardiovascular event rate in subjects identified as high risk
Through study completion, an average of 2 years
vision threatening retinopathy(VTDR) rate and rate of vision loss in subjects identified as high risk for VTDR
Through study completion, an average of 2 years
Study Arms (2)
National Heart Centre Singapore
At NHCS, patients who have undergone either CTCA or CT CAC scan within past 6 months will be identified. All the consented participants will have a one-off retinal imaging performed at the respective institution by the trained study team member, which should take approximately 15-20 minutes to complete. 3 to 4 questionnaires will also be administered (i.e. EQ5D, International Index of Erectile Function, Pittsburgh Sleep Quality Index, General Questionnaire), depending patient's gender and literacy. Only male patients who are literate in English language will be invited to complete the International Index of Erectile Function questionnaire. Participants have the option to not complete sthe whole IIEF questionnaire or some of the questions if they are not comfortable with answering those questions.
Singapore Eye Research Institute
At SERI, patients who are found to be at high risk for vision threatening diabetic retinopathy will be identified. All the consented participants will have a one-off retinal imaging performed at the respective institution by the trained study team member, which should take approximately 15-20 minutes to complete. 3 to 4 questionnaires will also be administered (i.e. EQ5D, International Index of Erectile Function, Pittsburgh Sleep Quality Index, General Questionnaire), depending patient's gender and literacy. Only male patients who are literate in English language will be invited to complete the International Index of Erectile Function questionnaire. Participants have the option to not complete sthe whole IIEF questionnaire or some of the questions if they are not comfortable with answering those questions.
Interventions
The retinal photography will be acquired from macula-centre and an optic-disc centre for both left and right eye after their cardiac assessment. Patient will be required to focus at a target inside the machine for approximately 5 to 10 seconds, with a flash followed at the end when eye image is captured. Based on patients' eye conditions, additional or less images may be taken. This allows a snapshot of both retinal and coronary vessels at a single point in time, no mydriatic drops will be used. Participants will be given the option to undergo mydriatic photographs of the retina at SNEC/SERI depending on participant eye condition. For mydriatic photograph, images will be obtained after pupil dilation and graded for presence and severity of diabetic retinopathy according to the modified ETDRS system and other retinal abnormalities by trained graders.
3 to 4 questionnaires will be administered (i.e. EQ5D, International Index of Erectile Function, Pittsburgh Sleep Quality Index, General Questionnaire) to investigate the correlation between clinical characteristics, lifestyle (eg. exercise, sleep, erectile dysfunction) and diet to retinal and coronary vasculature and outcomes.Only male patients who are literate in English language will be invited to complete the International Index of Erectile Function (IIEF) questionnaire. Participants have the option to not complete the whole IIEF questionnaire or some of the questions if they are not comfortable with answering those questions.
Eligibility Criteria
Participants that have recently undergone an investigation for heart in NHCS (such as computed tomographic coronary angiography \[CTCA\] or non-contrast computed tomography coronary artery calcium \[CAC\] imaging) or participants from SERI, who are diagnosed with Diabetes for more than or equal to 10 years
You may qualify if:
- years of age or older
- Sufficient language skills in English or Chinese
- Provided informed consent
- Completed CTCA or CT CAC in the past 6 months.
- years of age or older
- Sufficient language skills in English or Chinese
- Provided informed consent
- Patient diagnosed with Diabetes for more than or equal to 10 years.
You may not qualify if:
- Patients whose informed consent was not obtained.
- Age \<21 years old
- Patients with cardiac event (acute myocardial infarction, Stroke, heart failure, angina requiring hospitalization) and/or coronary revascularization (percutaneous coronary intervention (PCI) and/or coronary artery bypass grafting (CABG) prior to CTCA
- Patient whose informed consent was not obtained.
- Age \<21 years old
- Patients with cardiac event (acute myocardial infarction, Stroke, heart failure, angina requiring hospitalization) and/or coronary revascularization (percutaneous coronary intervention (PCI) and/or coronary artery bypass grafting (CABG) prior to CTCA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Heart Centre Singaporelead
- Singapore Eye Research Institutecollaborator
Study Sites (1)
National Heart Centre Singapore
Singapore, 169609, Singapore
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gavin Tan Siew Wei
Singapore National Eye Centre
- PRINCIPAL INVESTIGATOR
Weiting Huang
National Heart Centre Singapore
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2022
First Posted
November 23, 2022
Study Start
January 30, 2023
Primary Completion
June 30, 2024
Study Completion (Estimated)
June 30, 2027
Last Updated
November 23, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share