Coronary Artery DiseaseNCT05626517
JARVISDHL Screening Tools
An observational study of Coronary Artery Disease, run by National Heart Centre Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Ocular Imaging and Questionnaires
- How many people
- 2,000 participants
- Where
- 1 siteSingapore
- Study dates
- 30 Jan 2023to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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
Who may be able to join
- 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.
- 21 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site
National Heart Centre Singapore
Singapore, 169609
Weiting Huang, 9637 0396 ext. 6704 8964, huang.weiting@singhealth.com.sg
About this study
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Ocular Imaging, Questionnaires
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocular ImagingDiagnostic test
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.
QuestionnairesOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Ocular Imaging; Other: Questionnaires | |
| 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. Receives: Diagnostic Test: Ocular Imaging; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 2 years
Secondary outcomes (4)
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.
Measured: Through study completion, an average of 2 years
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
Measured: Through study completion, an average of 2 years
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.
Measured: 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
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.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start30 Jan 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Heart Centre Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore Eye Research Institute
- Responsible party
- Sponsor
- Investigators
- Gavin Tan Siew Wei, Principal investigator, Singapore National Eye CentreWeiting Huang, Principal investigator, National Heart Centre Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626517
- Sponsor's protocol ID
- R1869/111/2021
- Status last verified
- Sep 2022
- First submitted
- 13 Sep 2022
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- JARVISDHL Screening Tools
- ClinicalTrials.gov ID
- NCT05626517
- Acronym / sponsor ID
- R1869/111/2021
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- National Heart Centre SingaporeUniversity, hospital or other
- Collaborators
- Singapore Eye Research Institute
- Study start
- 30 Jan 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 23 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| National Heart Centre Singapore | – | Diagnostic Test: Ocular Imaging, Other: QuestionnairesAt 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 | – | Diagnostic Test: Ocular Imaging, Other: QuestionnairesAt 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. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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
Key inclusion criteria (8 listed)
- 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.
- 21 years of age or older
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ocular ImagingThe 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. | Diagnostic test | National Heart Centre Singapore, Singapore Eye Research Institute |
| Questionnaires3 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. | Other | National Heart Centre Singapore, Singapore Eye Research Institute |
Primary outcome
AI model and retinal imaging
Time frame: 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.
4 secondary outcomes
cross sectional performance of Cardiovascular risk stratification tool
Time frame: Through study completion, an average of 2 years
longitudinal major cardiovascular event rate in subjects identified as high risk
Time frame: Through study completion, an average of 2 years
major cardiovascular event rate in subjects identified as high risk
Time frame: 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
Time frame: Through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Coronary Artery Disease
Recruiting
Multivessel Balloon Occlusion to Investigate Obstructive Coronary Artery Disease and aNgina
Stable Angina, Multivessel Coronary Artery Disease
Not yet recruitingPhase 3
Efficacy of Lipoic Acid on Chronic Ischemic Heart Failure Patients
Heart Failure Due to Coronary Artery Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruitingObservational study
Prognostic Value of Functional-Nutritional Status in Older Adults With Acute Coronary Syndrome
Acute Coronary Syndromes (ACS)
RecruitingObservational study
Cardiovascular Acoustics for Early Disease Detection
Valvular Heart Disease, Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gavin Tan Siew Wei principal investigator
Singapore National Eye Centre
Weiting Huang principal investigator
National Heart Centre Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by National Heart Centre Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weiting Huang (9637 0396 ext. 6704 8964, huang.weiting@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AI model and retinal imaging (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2022.