JARVISDHL Screening Tools
ConditionCoronary Artery Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21-99
SponsorNational Heart Centre Singapore
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
21 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.
Disqualifiers
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.
Trial population
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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Ocular Imaging
Diagnostic testThe 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.
Questionnaires
Other intervention3 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.
Treatment groups
2,000 Participants
are divided into 2 treatment groupsGroup A: National Heart Centre Singapore2 interventions
Group B: Singapore Eye Research Institute2 interventions
Trial outcomes
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.
Time frame
Through study completion, an average of 2 yearsSecondary outcomes
1
cross sectional performance of Cardiovascular risk stratification tool
Evaluate the cross sectional performance of Cardiovascular risk stratification tool, SIVA-DLS and Retina-CAC for cardiovascular risk stratification compared with patients undergoing cardiac CT scan. Low risk is determined to be Agatston calcium score=0 and high risk being Agatston calcium score 100 and above.
Time frame
Through study completion, an average of 2 years2
longitudinal major cardiovascular event rate in subjects identified as high risk
Evaluate the longitudinal major cardiovascular event rate in subjects identified as high risk using a combination of cardiovascular risk stratification tool, SIVA DLS and Retina-CAC
Time frame
Through study completion, an average of 2 years3
major cardiovascular event rate in subjects identified as high risk
Evaluate if the major cardiovascular event rate in subjects identified as high risk and placed under medical intervention is lower compared to matched historical controls.
Time frame
Through study completion, an average of 2 years4
vision threatening retinopathy(VTDR) rate and rate of vision loss in subjects identified as high risk for VTDR
Evaluate if the vision threatening retinopathy(VTDR) rate and rate of vision loss in subjects identified as high risk for VTDR and placed in a VTDR clinic is lower compare to matched historical controls.
Time frame
Through study completion, an average of 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
National Heart Centre Singapore
Lead sponsor
Singapore Eye Research Institute
Collaborator
Source ClinicalTrials.gov
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