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NCT02885428 Clinical Trial

Detection no Invasive of a Silent Myocardial Ischemia

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02885428
Other study ID # 2014-A01458-39
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date April 15, 2015
Est. completion date April 17, 2018

Study information
Verified date October 2022
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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)

Recruitment information / eligibility
Status Terminated
Enrollment 47
Est. completion date April 17, 2018
Est. primary completion date April 15, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• echography

Locations
Country Name City State
France Les Hôpitaux Universitaires Strasbourg

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary diagnostic of the silent myocardial ischemia 80 minutes
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