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Clinical Trials in Singapore / NCT05626517
Starting soon Observational

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NCT05626517 · tracked via the Priya Life Science Singapore tracker
Phase
Observational
Started
2023-01-30
Last updated
2022-11-23

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

Ocular ImagingQuestionnaires

Ocular Imaging: 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.

Questionnaires: 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.

Study 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.

Eligibility

Sex
ALL
Min age
21 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria for NHCS: 1. 21 years of age or older 2. Sufficient language skills in English or Chinese 3. Provided informed consent 4. Completed CTCA or CT CAC in the past 6 months. Inclusion Criteria for SERI: 1. 21 years of age or older 2. Sufficient language skills in English or Chinese 3. Provided informed consent 4. Patient diagnosed with Diabetes for more than or equal to 10 years. Exclusion Criteria for NHCS: 1. Patients whose informed consent was not obtained. 2. Age \<21 years old 3. 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 Exclusion Criteria in SERI:- 1. Patient whose informed consent was not obtained. 2. Age \<21 years old 3. 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
National Heart Centre Singapore Singapore Singapore

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05626517 on ClinicalTrials.gov ↗ ← All trials in Singapore