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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
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
July 27, 2015
Last Updated
March 8, 2022
Sponsor
University Hospital, Caen
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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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