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Detection no Invasive of a Silent Myocardial Ischemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02885428
Recruitment Status : Unknown
Verified December 2016 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
First Posted : August 31, 2016
Last Update Posted : December 6, 2016
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief Summary:

The pathophysiological features of myocardial diabetic subject combined with cardiac autonomic neuropathy were behind the quietness of myocardial ischemia, known as silent myocardial ischemia (IMS). These patients have the risk to remain asymptomatic until the sudden onset of a myocardial infarction, or even sudden death.

That is why the investigators want to evaluate the contribution of non-invasive tools to stand in the diagnosis of IMS patients with diabetes type 2, asymptomatic heart on map: Technical myocardial speckle tracking in studying strains overall average left ventricular (longitudinal, circumferential and radial) measured in 2D and 3D at rest, compared to stress echocardiography with dobutamine (ESD)

Condition or disease Intervention/treatment
Silent Myocardial Ischemia Type 2 Diabetes Device: echography

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Silent Myocardial Ischemia in Patients With Diabetes Type 2: Diagnostic Value of Myocardial Strains Left Ventricular Resting Echocardiography 2D and 3D, Compared to Stress Echocardiography
Study Start Date : April 2015
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. diagnostic of the silent myocardial ischemia [ Time Frame: 80 minutes ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with type 2 diabetes, men or women, asymptomatic on the heart level, high risk

Inclusion Criteria:

  • With at least two cardiovascular risk factors including: hypertension, dyslipidemia, smoking active or interrupted for less than 3 years, family history (relatives of the 1st degree) Accident major CV before 60.
  • Or whatever the level of risk factors: peripheral artery disease and / or carotid atherosclerosis, or proteinuria

Exclusion Criteria:

  • Valvular heart disease (severe to moderate valvular ) , hypertrophic , dilated , chronic lung
  • History of cardiotoxic chemotherapy
  • Atrioventricular blocks of degree
  • Asthma
  • Recent stroke within a month
  • Bilateral carotid stenosis tight
  • Glaucoma untreated narrow angle
  • Subject to exclusion period (determined by a previous study or in progress)
  • Inability to give informed about information
  • patient under judicial protection
  • patient guardianship or curatorship
  • Current pregnancy (women of childbearing age )
  • Breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02885428

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Contact: Samy TALHA, MD
Contact: Emmanuel ANDRES, MD

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Les Hôpitaux Universitaires Recruiting
Strasbourg, France, 67091
Contact: Samy TALHA, MD   
Sub-Investigator: Emmanuel ANDRES, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
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Principal Investigator: Samy TALHA, MD Hôpitaux Universitaires de Strasbourg

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Responsible Party: University Hospital, Strasbourg, France Identifier: NCT02885428     History of Changes
Other Study ID Numbers: 2014-A01458-39
First Posted: August 31, 2016    Key Record Dates
Last Update Posted: December 6, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases