跳至主要内容
临床试验/NCT04025996
NCT04025996Unknown不适用

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

National Heart Centre Singapore1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年2月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Eye Examination

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
21 Years 至 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age greater than equal to 21 years old

排除标准

  • 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

结局指标

主要结局

Eye Examination

时间窗: 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.

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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