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

History of Changes

Tracking Information

First Received Date ^ICMJE

October 7, 2010

Last Updated Date

April 18, 2013

Start Date ^ICMJE

January 2011

Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01220349 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Alteration of Myocardial Deformations in Diabetes: Relationship to Micro-angiopathy

Official Title ^ICMJE

Early Detection of Diabetic Cardiomyopathy by Analysis of Myocardial Deformations by Two-dimensional Speckle Tracking Strain Echocardiography and Relationship to Micro-angiopathy

Brief Summary

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.

Detailed Description

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%).

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Diabetes Mellitus, Type 1

Intervention ^ICMJE

Device: Echocardiographic 2D strain analysis

Conventional transthoracic echocardiography with acquisitions for strain analysis by speckle tracking (2D strain)

Study Arm (s)

Experimental: Echocardiographic 2D strain analysis

Intervention: Device: Echocardiographic 2D strain analysis

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2012

Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01220349

Other Study ID Numbers ^ICMJE

CHUBX 2009/27

Has Data Monitoring Committee

Responsible Party

University Hospital, Bordeaux

Study Sponsor ^ICMJE

University Hospital, Bordeaux

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Patricia REANT, MD-PhD

University Hospital Bordeaux, France

Information Provided By

University Hospital, Bordeaux

Verification Date

April 2013

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

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