Relationship Between Left Ventricular Remodeling, Coronary Endothelial Function and Myocardial Fibrosis Using Positron Emission Tomography in Patients With ST-elevation Myocardial Infarction

NCT ID: NCT02789098

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

SUSPENDED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2023-03-31

Brief Summary

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Left ventricular remodeling is a common complication in patients with ST-elevation myocardial infarction (STEMI ) and may lead to heart failure. Hemodynamic, metabolic and inflammatory mechanisms are involved in this pathophysiological process. Recent data demonstrated that remote, noninfarct-related region of the myocardium is also implicated. There is no data about the assessment of coronary endothelial function or myocardial fibrosis in the remote zone in patients with STEMI . The correlation between these parameters and left ventricular remodeling is not known.

Detailed Description

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Conditions

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ST Elevation Myocardial Infarction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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STEMI

All patients included in this study (1 arm)

Group Type OTHER

(15)-O water positron emission tomography and Biomarkers

Intervention Type OTHER

Coronary endothelial function is assessed using (15)-O water positron emission tomography and cold pressor test . The response to the test is defined by the percentage increase myocardial blood flow . Assessment of fibrosis, inflammation an endothelial function is performed using biomarkers.

Interventions

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(15)-O water positron emission tomography and Biomarkers

Coronary endothelial function is assessed using (15)-O water positron emission tomography and cold pressor test . The response to the test is defined by the percentage increase myocardial blood flow . Assessment of fibrosis, inflammation an endothelial function is performed using biomarkers.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* First ST Elevation Myocardial Infarction
* Primary Percutaneous Coronary Intervention (TIMI 3)
* Single vessel coronary artery disease
* Age over 18 years
* Informed Consent dated and signed
* Written and spoken French
* Beneficiary of social security insurance

Exclusion Criteria

* No Primary Percutaneous Coronary Intervention
* TIMI 0-2 after Primary Percutaneous Coronary Intervention
* Significant two or three-vessel coronary artery disease (\> 70% stenosis in at least one of the other two coronary arteries)
* Past history of myocardial infarction before STEMI
* Mechanical complication (ischaemic mitral regurgitation, interventricular septal defect, cardiac tamponade) or clinical signs of heart failure
* 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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Société Française de Cardiologie

OTHER

Sponsor Role collaborator

University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Farzin GF BEYGUI, PhD

Role: STUDY_CHAIR

CHU CAEN

Alain MA Manrique, PhD

Role: STUDY_CHAIR

CHU CAEN

Locations

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CHu de Caen

Caen, Normandy, France

Site Status

Countries

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France

Other Identifiers

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2015-A01650-49

Identifier Type: -

Identifier Source: org_study_id

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