JARVISDHL Screening Tools
- Conditions
- Coronary Artery Disease
- Interventions
- Diagnostic Test: Ocular ImagingOther: Questionnaires
- Registration Number
- NCT05626517
- Lead Sponsor
- National Heart Centre Singapore
- 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 2000
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description National Heart Centre Singapore Ocular Imaging 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. National Heart Centre Singapore Questionnaires 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 Ocular Imaging 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. Singapore Eye Research Institute Questionnaires 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.
- Primary Outcome Measures
Name Time Method AI model and retinal imaging Through study completion, an average of 2 years 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.
- Secondary Outcome Measures
Name Time Method cross sectional performance of Cardiovascular risk stratification tool Through study completion, an average of 2 years 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.
longitudinal major cardiovascular event rate in subjects identified as high risk Through study completion, an average of 2 years 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
major cardiovascular event rate in subjects identified as high risk Through study completion, an average of 2 years 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.
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 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.
Trial Locations
- Locations (1)
National Heart Centre Singapore
🇸🇬Singapore, Singapore