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出境医 / 临床实验 / REWARD: Using the REtina as a Window To Detect Cardiac microvasculAR Dysfunction In Diabetes Mellitus

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

Study Description
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.

Condition or disease Intervention/treatment
Retinopathy, Diabetic Diastolic Dysfunction Microalbuminuria Diagnostic Test: Cardiac Assessments and Eye Assessments

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 Design
Layout table for study information
Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Using the REtina as a Window To Detect Cardiac microvasculAR Dysfunction In Diabetes Mellitus
Actual Study Start Date : February 20, 2018
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021
Arms 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
Outcome Measures
Primary Outcome Measures :
  1. Eye Examination [ Time Frame: 1 day ]
    Retinal photography on diabetic patients will be performed to identify those with retinopathy.

  2. 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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   21 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients who have known heart condition and type II diabetes.
Criteria

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
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Thng Ai Ling Sandra +65 6704 2279 sandra.thng.a.l@nhcs.com.sg
Contact: Tan Ying Zhen Janice +65 6704 2229 janice.tan.y.z@nhcs.com.sg

Locations
Layout table for location information
Singapore
National Heart Centre Singapore Recruiting
Singapore, Singapore, 169609
Sponsors and Collaborators
National Heart Centre Singapore
Singapore National Eye Centre
Tracking Information
First Submitted Date April 4, 2018
First Posted Date July 19, 2019
Last Update Posted Date February 3, 2021
Actual Study Start Date February 20, 2018
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 16, 2019)
  • Eye Examination [ Time Frame: 1 day ]
    Retinal 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. [ 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title REWARD: Using the REtina as a Window To Detect Cardiac microvasculAR Dysfunction In Diabetes Mellitus
Official Title Using the REtina as a Window To Detect Cardiac microvasculAR Dysfunction In Diabetes Mellitus
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients who have known heart condition and type II diabetes.
Condition
  • Retinopathy, Diabetic
  • Diastolic Dysfunction
  • Microalbuminuria
Intervention 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
Study Groups/Cohorts Diseased Group
Patients with type 2 diabetic retinopathy and known cardiac dysfunction.
Intervention: Diagnostic Test: Cardiac Assessments and Eye Assessments
Publications *
  • Phan K, Mitchell P, Liew G, Plant AJ, Wang SB, Au C, Chiha J, Kovoor P, Thiagalingam A, Burlutsky G, Gopinath B. Association between Retinal Arteriolar and Venule Calibre with Prevalent Heart Failure: A Cross-Sectional Study. PLoS One. 2015 Dec 11;10(12):e0144850. doi: 10.1371/journal.pone.0144850. eCollection 2015.
  • Wong TY, Rosamond W, Chang PP, Couper DJ, Sharrett AR, Hubbard LD, Folsom AR, Klein R. Retinopathy and risk of congestive heart failure. JAMA. 2005 Jan 5;293(1):63-9.
  • Lam CS, Roger VL, Rodeheffer RJ, Bursi F, Borlaug BA, Ommen SR, Kass DA, Redfield MM. Cardiac structure and ventricular-vascular function in persons with heart failure and preserved ejection fraction from Olmsted County, Minnesota. Circulation. 2007 Apr 17;115(15):1982-90. Epub 2007 Apr 2. Erratum in: Circulation. 2007 May 22;115(20):e535.
  • Lam CS, Lyass A, Kraigher-Krainer E, Massaro JM, Lee DS, Ho JE, Levy D, Redfield MM, Pieske BM, Benjamin EJ, Vasan RS. Cardiac dysfunction and noncardiac dysfunction as precursors of heart failure with reduced and preserved ejection fraction in the community. Circulation. 2011 Jul 5;124(1):24-30. doi: 10.1161/CIRCULATIONAHA.110.979203. Epub 2011 Jun 13. Erratum in: Circulation. 2011 Oct 25;124(17):e458.
  • Teo LY, Chan LL, Lam CS. Heart failure with preserved ejection fraction in hypertension. Curr Opin Cardiol. 2016 Jul;31(4):410-6. doi: 10.1097/HCO.0000000000000292. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 16, 2019) 		60
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 31, 2021
Estimated Primary Completion Date May 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Thng Ai Ling Sandra +65 6704 2279 sandra.thng.a.l@nhcs.com.sg
Contact: Tan Ying Zhen Janice +65 6704 2229 janice.tan.y.z@nhcs.com.sg
Listed Location Countries Singapore
Removed Location Countries  
 
Administrative Information
NCT Number NCT04025996
Other Study ID Numbers 2017/2592
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party National Heart Centre Singapore
Study Sponsor National Heart Centre Singapore
Collaborators Singapore National Eye Centre
Investigators Not Provided
PRS Account National Heart Centre Singapore
Verification Date September 2020

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