Alteration of Myocardial Deformations in Diabetes: Relationship to Micro-angiopathy (ECHO-DIAB)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01220349
First received: October 7, 2010
Last updated: April 18, 2013
Last verified: April 2013

October 7, 2010
April 18, 2013
January 2011
October 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01220349 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Alteration of Myocardial Deformations in Diabetes: Relationship to Micro-angiopathy
Early Detection of Diabetic Cardiomyopathy by Analysis of Myocardial Deformations by Two-dimensional Speckle Tracking Strain Echocardiography and Relationship to Micro-angiopathy

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.

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%).

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Diabetes Mellitus, Type 1
Device: Echocardiographic 2D strain analysis
Conventional transthoracic echocardiography with acquisitions for strain analysis by speckle tracking (2D strain)
Experimental: Echocardiographic 2D strain analysis
Intervention: Device: Echocardiographic 2D strain analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
October 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Both
18 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01220349
CHUBX 2009/27
No
University Hospital, Bordeaux
University Hospital, Bordeaux
Not Provided
Principal Investigator: Patricia REANT, MD-PhD University Hospital Bordeaux, France
University Hospital, Bordeaux
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP