Skip to content

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04025996
Enrollment
60
Registered
2019-07-19
Start date
2018-02-20
Completion date
2021-05-31
Last updated
2021-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diastolic Dysfunction, Microalbuminuria, Retinopathy, Diabetic

Brief 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.

Interventions

DIAGNOSTIC_TESTCardiac 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

Sponsors

Singapore National Eye Centre
CollaboratorOTHER_GOV
National Heart Centre Singapore
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to 120 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Eye Examination1 dayRetinal photography on diabetic patients will be performed to identify those with retinopathy.
Cross-sectional analyses will be performed to look at the association between diabetic retinopathy with left ventricular diastolic function, coronary flow reserve and urinary albumin excretion.2 daysThese data will provide initial evidence of the mechanistic link between microvascular dysfunction in the eye, heart and kidneys among patients with diabetes.

Countries

Singapore

Contacts

Primary ContactThng Ai Ling Sandra
sandra.thng.a.l@nhcs.com.sg+65 6704 2279
Backup ContactTan Ying Zhen Janice
janice.tan.y.z@nhcs.com.sg+65 6704 2229

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026