Silent Myocardial IschemiaNCT02885428
Detection no Invasive of a Silent Myocardial Ischemia
An observational study of Silent Myocardial Ischemia and Type 2 Diabetes, run by University Hospital, Strasbourg, France at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Silent Myocardial Ischemia, Type 2 Diabetes
- What is being tested?
- echography
- Type of treatment
- Medical device
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2015to 17 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with type 2 diabetes, men or women, asymptomatic on the heart level, high risk
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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)
- Conditions
- Silent Myocardial Ischemia, Type 2 Diabetes
- Being tested
- echography
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
echographyDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic of the silent myocardial ischemia
Measured: 80 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study start15 Apr 2015
- Primary completion15 Apr 2015
- Study completion17 Apr 2018
Why it stopped: Difficulties in the inclusion of patients with cardiacly asymptomatic type 2 diabetes and with at least two cardiovascular risk factors.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Silent Myocardial IschemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samy TALHA, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885428
- Sponsor's protocol ID
- 2014-A01458-39
- Status last verified
- Oct 2022
- First submitted
- 26 Aug 2016
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02885428
- Acronym / sponsor ID
- 2014-A01458-39
- Conditions
- Silent Myocardial Ischemia, Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulties in the inclusion of patients with cardiacly asymptomatic type 2 diabetes and with at least two cardiovascular risk factors.
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 15 Apr 2015 (actual)
- Primary completion
- 15 Apr 2015 (actual)
- Study completion
- 17 Apr 2018 (actual)
- First posted
- 31 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with type 2 diabetes, men or women, asymptomatic on the heart level, high risk
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| echography | Device | – |
Primary outcome
diagnostic of the silent myocardial ischemia
Time frame: 80 minutes
Results and safety
The study was stopped early (reason given: Difficulties in the inclusion of patients with cardiacly asymptomatic type 2 diabetes and with at least two cardiovascular risk factors.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samy TALHA, MD principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Silent Myocardial Ischemia and Type 2 Diabetes, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulties in the inclusion of patients with cardiacly asymptomatic type 2 diabetes and with at least two cardiovascular risk factors.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic of the silent myocardial ischemia (time frame: 80 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.