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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 August 2015 |
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Main ID: |
NCT02510703 |
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Date of registration:
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27/07/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Assessment of Coronary Endothelial Function in Diabetic Patients With Acute Coronary Syndrome Using 15O-water Positron Emission Tomography
D-TEP |
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Scientific title:
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Date of first enrolment:
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March 2011 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02510703 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Alain MANRIQUE, MD, PhD |
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Address:
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Telephone:
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02 31 06 31 06 |
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with a first myocardial infarction, type 2 diabetic or non-diabetic treated
by angioplasty in acute phase (TIMI 3)
- Myocardial viability test before discharge
- Age over 18 years
- Informed Consent dated and signed by the patient
- Written and spoken French
- Beneficiary of social security insurance
Exclusion Criteria:
- Hypertension> 160/90 mmHg despite medical treatment
- Lack of effective revascularization in acute phase of myocardial infarction (TIMI
grade <3)
- Significant three-vessel coronary artery disease (> 70% stenosis in the other two
coronary arteries); occlusion of a coronary artery; schedule revascularization
(percutaneous or surgical); left main coronary artery stenosis
- Previous history of myocardial infarction
- Mechanical complication (mitral regurgitation, ventricular septal rupture, left
ventricular free wall rupture)
- Heart failure
- No myocardial viability test before discharge, for whatever reason
- Type 1 diabetes
- Pregnant and / or lactating
- Age under 18 years or guardianship
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Myocardial Infarction
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Intervention(s)
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Other: Coronary endothelial function measurements by quantitative method (TEP at 15O-H2O)
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Primary Outcome(s)
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Comparison of quantitative variables coronary endothelial function in PET according to the presence or absence of type 2 diabetes in patients investigated with the waning of a first heart attack
[Time Frame: baseline]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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