D-TEP: Assessment of Coronary Endothelial Function in Diabetic Patients With Acute Coronary Syndrome Using 15O-water Positron Emission Tomography

Sponsor

University Hospital, Caen (Other)

Overall Status

Completed

CT.gov ID

NCT02510703

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction	Other: Coronary endothelial function measurements by quantitative method (TEP at 15O-H2O)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Study Start Date :

Mar 1, 2011

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: Type 2 diabetes group Type 2 diabetes group	Other: Coronary endothelial function measurements by quantitative method (TEP at 15O-H2O)
Other: no diabetes no diabetes	Other: Coronary endothelial function measurements by quantitative method (TEP at 15O-H2O)

Arm

Intervention/Treatment

Other: Type 2 diabetes group

Type 2 diabetes group

Other: Coronary endothelial function measurements by quantitative method (TEP at 15O-H2O)

Other: no diabetes

no diabetes

Other: Coronary endothelial function measurements by quantitative method (TEP at 15O-H2O)

Outcome Measures

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 [baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service de Cardiologie	Caen		France	14000

Sponsors and Collaborators

University Hospital, Caen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Caen

ClinicalTrials.gov Identifier:

NCT02510703

Other Study ID Numbers:

09-085

First Posted:

Jul 29, 2015

Last Update Posted:

Mar 22, 2022

Last Verified:

Aug 1, 2015

Additional relevant MeSH terms:

Myocardial Infarction

Infarction

Study Results

No Results Posted as of Mar 22, 2022