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UnknownNCT04025996

REWARD: Using the REtina as a Window To Detect Cardiac microvasculAR Dysfunction In Diabetes Mellitus

Using the REtina as a Window To Detect Cardiac microvasculAR Dysfunction In Diabetes Mellitus

Status
Unknown
Phase
Study type
Observational
Enrollment
60 (estimated)
Sponsor
National Heart Centre Singapore · Academic / Other
Sex
All
Age
21 Years – 120 Years
Healthy volunteers
Accepted

Summary

Retinopathy may be associated with diastolic dysfunction and/or coronary flow reserve in the heart, and albuminuria in diabetic patients. The objective of this study is to examine the cross-sectional relationships of retinopathy with indices of left ventricular diastolic function, coronary flow reserve and urinary albumin excretion, among diabetic patients.

Detailed description

Diabetes is a potent risk factor for macrovascular coronary disease, leading to systolic dysfunction and heart failure. More recently diabetic microvascular disease has been recognized to play a key role in the development of diastolic dysfunction and heart failure with preserved ejection fraction. A new paradigm in diabetic heart disease centers on microvascular endothelial dysfunction involving the intra-myocardial capillaries and leading to cardiomyocyte dysfunction and diastolic dysfunction. This is analogous to the microvascular dysfunction well-described in the diabetic retinopathy and nephropathy. Yet, whereas diabetic retinal screening for retinopathy and screening for microalbuminuria are routine, diabetic cardiac screening for microvascular dysfunction is practically non-existent. The retinal vasculature may represent a window of opportunity to detect concurrent microvascular disease in the heart and kidneys before the onset of clinical symptoms. However, there are limited studies that directly attempt to correlate retinopathy to diastolic dysfunction and microalbuminuria. Hence this study aims to examine the cross-sectional relationships of retinopathy with indices of left ventricular diastolic function, coronary flow reserve and urinary albumin excretion, among diabetic patients.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTCardiac Assessments and Eye AssessmentsCardiac Assessments, include the following: * transthoracic echocardiography * computed tomography of coronary arteries * position emission tomography computed tomography or single photon emission tomography computed tomography Eye examinations, include the following: * pupil dilation * retinal photography * dynamic vessel analyser * IOL master

Timeline

Start date
2018-02-20
Primary completion
2021-05-31
Completion
2021-05-31
First posted
2019-07-19
Last updated
2021-02-03

Locations

1 site across 1 country: Singapore

Source: ClinicalTrials.gov record NCT04025996. Inclusion in this directory is not an endorsement.