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

NCT ID: NCT02510703

Last Updated: 2022-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Myocardial Infarction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Type 2 diabetes group

Type 2 diabetes group

Group Type OTHER

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

Intervention Type OTHER

no diabetes

no diabetes

Group Type OTHER

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

Intervention Type OTHER

Interventions

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

Intervention Type OTHER

Eligibility 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service de Cardiologie

Caen, , France

Site Status

Countries

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France

Other Identifiers

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09-085

Identifier Type: -

Identifier Source: org_study_id

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