Early Detection of Diabetic Cardiomyopathy by Analysis of Myocardial Deformations by Two-dimensional Speckle Tracking Strain Echocardiography and Relationship to Micro-angiopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Measurement of the alteration of left ventricular myocardial strain (≤ 18% in absolute value) by echocardiography and the relationship to micro-angiopathy.
研究概览
简要总结
Despite careful monitoring of patients with diabetes, it is so far difficult to predict the occurrence of cardiac events in the evolution. As shown by various studies conducted in patients with diabetes, cardiac involvement can be detected by abnormalities of diastolic or systolic functions using non-invasive investigations such as echocardiography. For 4 years, the evaluation technique of myocardial deformations by two-dimensional speckle tracking strain by echocardiography is the subject of high hopes in the earlier detection of still asymptomatic cardiomyopathies. In the present study, the investigators hypothesized that this technique would improve the detection of myocardial contraction abnormalities in patients with insulin-dependent diabetes mellitus (IDDM), and would establish their association with micro-angiopathy, frequently encountered in these patients.
详细描述
This is a single center case-control study based on routine care, designed to recruit patients with type 1 diabetes mellitus free from any other myocardiopathy. The inclusion will take place over a period of 24 months. No monitoring of patients (no follow-up) is provided under this protocol. The analysis will focus on the combination of the left ventricle myocardial deformations alteration revealed by the echocardiographic 2D strain analysis (< 18% in absolute value), with the existence of micro-angiopathy in type 1 diabetes mellitus patients with preserved left ventricular ejection fraction ( ≥ 60%).
Two hundred subjects with type 1 diabetes mellitus will be recruited: 100 subjects with impaired left ventricular myocardial deformation by 2D strain analysis (< 18% in absolute value), constituting the 'cases' group and 100 subjects without alteration in myocardial deformation (global strain ≥ 18%).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 18 and 45 years
- •with diagnosed Type 1 diabetes mellitus (with or without complications or peripheric vascular micro-angiopathy)
- •having a negative myocardial ischemic test (exercise echocardiography) in the previous month inclusion
排除标准
- •Known or suspected coronary artery disease
- •atrial fibrillation
- •hypertension
- •moderate to severe valvular disease
- •sequelae of myocardial infarction
- •secondary or primary cardiomyopathy
- •myocardial conduction abnormalities
- •pregnancy or breastfeeding.
研究组 & 干预措施
Echocardiographic 2D strain analysis
干预措施: Echocardiographic 2D strain analysis (Device)
结局指标
主要结局
Measurement of the alteration of left ventricular myocardial strain (≤ 18% in absolute value) by echocardiography and the relationship to micro-angiopathy.
时间窗: Inclusion : Day 1
次要结局
- Analyses of this association (alteration of myocardial strain and micro-angiopathy) in relation with the duration of diabetes, and other co-factors such as dyslipidemia, unstable diabetes, and coexisting macro-angiopathy.(Inclusion : Day 1)