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

Diabetes Mellitus, Type 1 Clinical Trial

— ECHO-DIAB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01220349
• Other study ID #: CHUBX 2009/27
• Status: Completed
• Phase: N/A
• First received: October 7, 2010
• Last updated: April 18, 2013
• Start date: January 2011
• Est. completion date: October 2012

Study information

• Verified date: April 2013
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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%).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

Device:
• Echocardiographic 2D strain analysis
Conventional transthoracic echocardiography with acquisitions for strain analysis by speckle tracking (2D strain)

Locations

Country	Name	City	State
France	Hôpital Cardiologique du Haut-Lévêque, Service de Cardiologie et Maladies Vasculaires	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of the alteration of left ventricular myocardial strain (= 18% in absolute value) by echocardiography and the relationship to micro-angiopathy.		Inclusion : Day 1	Yes
Secondary	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	Yes