Assessment of Coronary Endothelial Function in Diabetic Patients With Acute Coronary Syndrome Using 15O-water Positron Emission Tomography (D-TEP)
Primary Purpose
Myocardial Infarction
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Coronary endothelial function measurements by quantitative method (TEP at 15O-H2O)
Sponsored by
About this trial
This is an interventional diagnostic trial for Myocardial Infarction
Eligibility Criteria
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
Sites / Locations
- Service de Cardiologie
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Type 2 diabetes group
no diabetes
Arm Description
Type 2 diabetes group
no diabetes
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02510703
Brief Title
Assessment of Coronary Endothelial Function in Diabetic Patients With Acute Coronary Syndrome Using 15O-water Positron Emission Tomography
Acronym
D-TEP
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Type 2 diabetes is associated with early and diffuse abnormalities of endothelial function, especially in the coronary arteries, which are a factor of poor prognosis. Following acute coronary syndrome, the endothelial function abnormalities usually persist for several weeks before regressing. Their persistence 6-8 weeks after myocardial infarction is a poor prognostic factor. Investigators assume that global abnormalities of endothelial function in patients with diabetes may be additive with segmental abnormalities in revascularized myocardium, and contribute to worsening the prognosis in these patients. Furthermore, there is no published data showing any relationship between calcium score and endothelial function abnormalities in these patients. The investigators seek a relationship between calcium score and persistence of abnormalities of coronary endothelial function in these patients.
The main objective of this study was to compare coronary endothelial function by quantitative method (TEP at 15O-H2O) in diabetic patients and nondiabetic following acute coronary syndrome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Type 2 diabetes group
Arm Type
Other
Arm Description
Type 2 diabetes group
Arm Title
no diabetes
Arm Type
Other
Arm Description
no diabetes
Intervention Type
Other
Intervention Name(s)
Coronary endothelial function measurements by quantitative method (TEP at 15O-H2O)
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Service de Cardiologie
City
Caen
ZIP/Postal Code
14000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Assessment of Coronary Endothelial Function in Diabetic Patients With Acute Coronary Syndrome Using 15O-water Positron Emission Tomography
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