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

Not Applicable

Completed

• Conditions: Myocardial Infarction
• Interventions: Other: Coronary endothelial function measurements by quantitative method (TEP at 15O-H2O)

• Registration Number: NCT02510703
• Lead Sponsor: University Hospital, Caen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2015-07-27
• Study First Submitted QC: 2015-07-28
• Study First Posted: 2015-07-29
• Status Verified: 2015-08
• Primary Completion: 2015-12
• Study Completion: 2016-06
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
no diabetes	Coronary endothelial function measurements by quantitative method (TEP at 15O-H2O)	no diabetes
Type 2 diabetes group	Coronary endothelial function measurements by quantitative method (TEP at 15O-H2O)	Type 2 diabetes group

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Service de Cardiologie; 🇫🇷 Caen, France