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

March 8, 2022 updated by: University Hospital, Caen

Assessment of Coronary Endothelial Function and Myocardial Fibrosis in Positron Emission Tomography With the Waning of Acute Coronary Syndrome With Elevated ST Segment : Relationship With Left Ventricular Remodeling

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Normandie
      • Caen, Normandie, France, 14000
        • CHU de CAEN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: STEMI
All patients included in this study (1 arm)
Other: (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of coronary endothelial function
Time Frame: 3 months
3 months following an acute coronary syndrome STEMI an ST segment (segments in myocardial infarcted area and "remote" ) .
3 months
Measurement of fibrosis
Time Frame: 3 months
3 months following an acute coronary syndrome STEMI an ST segment (segments in myocardial infarcted area and "remote" ) .
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlating biomarkers with local and global parameters of coronary endothelial function , inflammation and myocardial fibrosis with early echocardiographic parameters of left ventricular remodeling and cardiac magnetic resonance imaging
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Collaborators

Société Française de Cardiologie

Investigators

  • Study Chair: Farzin GF BEYGUI, PhD, CHU Caen
  • Study Chair: Alain MA Manrique, PhD, CHU Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

April 21, 2016

First Submitted That Met QC Criteria

May 27, 2016

First Posted (Estimate)

June 2, 2016

Study Record Updates

Last Update Posted (Actual)

March 22, 2022

Last Update Submitted That Met QC Criteria

March 8, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-A01650-49

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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