JARVISDHL Screening Tools

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест 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.
• Другое 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 th

Первичные конечные точки

• AI model and retinal imaging [Срок оценки: Through study completion, an average of 2 years]

Вторичные конечные точки (4)

• cross sectional performance of Cardiovascular risk stratification tool [Срок оценки: Through study completion, an average of 2 years]
• longitudinal major cardiovascular event rate in subjects identified as high risk [Срок оценки: Through study completion, an average of 2 years]
• major cardiovascular event rate in subjects identified as high risk [Срок оценки: 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 [Срок оценки: Through study completion, an average of 2 years]

Критерии участия

Inclusion Criteria for NHCS:

• 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.

Inclusion Criteria for SERI:

• 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.

Exclusion Criteria for NHCS:

• 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

Exclusion Criteria in SERI:-

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Сингапур · 1 центр

• National Heart Centre Singapore — Singapore

Идентификаторы

NCT: NCT05626517 · R1869/111/2021

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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