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

February 2, 2021 updated by: National Heart Centre Singapore

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Singapore
      • Singapore, Singapore, 169609
        • Recruiting
        • National Heart Centre Singapore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who have known heart condition and type II diabetes.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diseased Group
Patients with type 2 diabetic retinopathy and known cardiac dysfunction.
Diagnostic test: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eye Examination
Time Frame: 1 day
Retinal photography on diabetic patients will be performed to identify those with retinopathy.
1 day
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.
Time Frame: 2 days
These data will provide initial evidence of the mechanistic link between microvascular dysfunction in the eye, heart and kidneys among patients with diabetes.
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart Centre Singapore

Collaborators

Singapore National Eye Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2018

Primary Completion (Anticipated)

May 31, 2021

Study Completion (Anticipated)

May 31, 2021

Study Registration Dates

First Submitted

April 4, 2018

First Submitted That Met QC Criteria

July 16, 2019

First Posted (Actual)

July 19, 2019

Study Record Updates

Last Update Posted (Actual)

February 3, 2021

Last Update Submitted That Met QC Criteria

February 2, 2021

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/2592

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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