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

Not Applicable

Suspended

• Conditions: ST Elevation Myocardial Infarction

• Registration Number: NCT02789098
• Lead Sponsor: University Hospital, Caen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-21
• Study First Submitted QC: 2016-05-27
• Study Start: 2016-06
• Study First Posted: 2016-06-02
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-22
• Primary Completion: 2022-08
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	3 months

Trial Locations

Locations (1)

CHu de Caen; 🇫🇷 Caen, Normandie, France