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

Primary Purpose

ST Elevation Myocardial Infarction

Status
Suspended
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
(15)-O water positron emission tomography and Biomarkers
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for ST Elevation Myocardial Infarction focused on measuring ST Elevation Myocardial Infarction, Ventricular remodeling, Biomarkers, Coronary endothelial function, Positron Emission Tomography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHu de Caen

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

STEMI

Arm Description

All patients included in this study (1 arm)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 21, 2016
Last Updated
March 8, 2022
Sponsor
University Hospital, Caen
Collaborators
Société Française de Cardiologie
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1. Study Identification

Unique Protocol Identification Number
NCT02789098
Brief Title
Relationship Between Left Ventricular Remodeling, Coronary Endothelial Function and Myocardial Fibrosis Using Positron Emission Tomography in Patients With ST-elevation Myocardial Infarction
Acronym
REMOD-TEP
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Suspended
Why Stopped
Technical issues.
Study Start Date
June 2016 (undefined)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen
Collaborators
Société Française de Cardiologie

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevation Myocardial Infarction
Keywords
ST Elevation Myocardial Infarction, Ventricular remodeling, Biomarkers, Coronary endothelial function, Positron Emission Tomography

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
STEMI
Arm Type
Other
Arm Description
All patients included in this study (1 arm)
Intervention Type
Other
Intervention Name(s)
(15)-O water positron emission tomography and Biomarkers
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measurement of coronary endothelial function
Description
3 months following an acute coronary syndrome STEMI an ST segment (segments in myocardial infarcted area and "remote" ) .
Time Frame
3 months
Title
Measurement of fibrosis
Description
3 months following an acute coronary syndrome STEMI an ST segment (segments in myocardial infarcted area and "remote" ) .
Time Frame
3 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farzin GF BEYGUI, PhD
Organizational Affiliation
CHU Caen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alain MA Manrique, PhD
Organizational Affiliation
CHU Caen
Official's Role
Study Chair
Facility Information:
Facility Name
CHu de Caen
City
Caen
State/Province
Normandie
ZIP/Postal Code
14000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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