Study Stopped
Difficulties in the inclusion of patients with cardiacly asymptomatic type 2 diabetes and with at least two cardiovascular risk factors.
Detection no Invasive of a Silent Myocardial Ischemia
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
1 other identifier
observational
47
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2015
CompletedFirst Submitted
Initial submission to the registry
August 26, 2016
CompletedFirst Posted
Study publicly available on registry
August 31, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 17, 2018
CompletedOctober 13, 2022
October 1, 2022
Same day
August 26, 2016
October 10, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
diagnostic of the silent myocardial ischemia
80 minutes
Interventions
Eligibility Criteria
Subjects with type 2 diabetes, men or women, asymptomatic on the heart level, high risk
You may qualify if:
- 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
You may not qualify if:
- 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
- Inability to give informed about information
- patient under judicial protection
- patient guardianship or curatorship
- Current pregnancy (women of childbearing age )
- Breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Les Hôpitaux Universitaires
Strasbourg, 67091, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Samy TALHA, MD
Hôpitaux Universitaires de Strasbourg
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2016
First Posted
August 31, 2016
Study Start
April 15, 2015
Primary Completion
April 15, 2015
Study Completion
April 17, 2018
Last Updated
October 13, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share