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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-20

Study Completion Date

2021-05-31

Brief Summary

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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.

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Detailed Description

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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

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Retinopathy, Diabetic Diastolic Dysfunction Microalbuminuria

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Diseased Group

Patients with type 2 diabetic retinopathy and known cardiac dysfunction.

Cardiac Assessments and Eye Assessments

Intervention Type DIAGNOSTIC_TEST

Cardiac 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

Interventions

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Cardiac Assessments and Eye Assessments

Cardiac 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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age greater than equal to 21 years old

Exclusion Criteria

* Known history of active eye lens or corneal opacity
* Known allergy to eye drops
* Kidney disease with estimated GFR \< 60
* Pregnant or lactating women
* Asthmatic status of the moderate persistent and above categories
* Chronic obstructive pulmonary disease
* Thyroid dysfunction

Minimum Eligible Age

21 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes