Detection no Invasive of a Silent Myocardial Ischemia

October 10, 2022 updated by: University Hospital, Strasbourg, France

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

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)

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

47

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67091
        • Les Hôpitaux Universitaires

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with type 2 diabetes, men or women, asymptomatic on the heart level, high risk

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
diagnostic of the silent myocardial ischemia
Time Frame: 80 minutes
80 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 15, 2015

Primary Completion (ACTUAL)

April 15, 2015

Study Completion (ACTUAL)

April 17, 2018

Study Registration Dates

First Submitted

August 26, 2016

First Submitted That Met QC Criteria

August 26, 2016

First Posted (ESTIMATE)

August 31, 2016

Study Record Updates

Last Update Posted (ACTUAL)

October 13, 2022

Last Update Submitted That Met QC Criteria

October 10, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-A01458-39

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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