Alteration of Myocardial Deformations in Diabetes: Relationship to Micro-angiopathy (ECHO-DIAB)
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Early Detection of Diabetic Cardiomyopathy by Analysis of Myocardial Deformations by Two-dimensional Speckle Tracking Strain Echocardiography and Relationship to Micro-angiopathy|
- Measurement of the alteration of left ventricular myocardial strain (≤ 18% in absolute value) by echocardiography and the relationship to micro-angiopathy. [ Time Frame: Inclusion : Day 1 ] [ Designated as safety issue: Yes ]
- 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. [ Time Frame: Inclusion : Day 1 ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2011|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
|Experimental: Echocardiographic 2D strain analysis||
Device: Echocardiographic 2D strain analysis
Conventional transthoracic echocardiography with acquisitions for strain analysis by speckle tracking (2D strain)
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%).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01220349
|Hôpital Cardiologique du Haut-Lévêque, Service de Cardiologie et Maladies Vasculaires|
|Pessac, France, 33604|
|Principal Investigator:||Patricia REANT, MD-PhD||University Hospital Bordeaux, France|