JARVISDHL Screening Tools

Singapore Health Services (SingHealth)

Status: Not yet enrolling

Conditions: Coronary Artery Disease

Treatments: Other: Questionnaires; Diagnostic Test: Ocular Imaging

Study type: Observational

Funder types: Other

Identifiers

NCT05626517

R1869/111/2021

Details and patient eligibility

About

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.

Full description

Cardiovascular disease (CVD) is ranked 1st for mortality rate globally. In 2016, approximately 17.9 million people died from CVDs, representing 31% of all global deaths.

Retinal vasculature has been characterised as the 'window' to the body's circulatory system and been correlated with several diseases that perturbate systemic micro- and macro-vasculature such as hypertension, stroke and chronic kidney disease.

As microvascular changes often precede macrovascular changes, retinal imaging has the capability to be an easily available, non-invasive biomarker to screen for multiple vascular pathologies. A deep learning system (DLS) is a novel,state-of-art artificial intelligence (AI) technology that has achieved robust diagnostic performance for medical imaging analysis. The integration of deep learning (DL) into retinal image evaluation has accelerated its potential further. Its examination of fundus photographs has demonstrated abilities to detect several signs that are undetected by the human eye. With recent correlations being established between CAD and retinal vasculature aberrancies such as reduced calibres and fractal dimensions, there is a clear niche for AI to predict cardiac diseases with the use of retinal fundus photographs.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 21 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

2,000 participants in 2 patient groups

National Heart Centre Singapore

Description:

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.

Treatment:

Other: Questionnaires

Diagnostic Test: Ocular Imaging

Singapore Eye Research Institute

Description:

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.

Treatment:

Other: Questionnaires

Diagnostic Test: Ocular Imaging