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

ST Elevation Myocardial Infarction Clinical Trial

— 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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02789098
• Other study ID #: 2015-A01650-49
• Status: Suspended
• Phase: N/A
• Start date: June 2016
• Est. completion date: March 2023

Study information

• Verified date: March 2022
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 30
• Est. completion date: March 2023
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• Ventricular Remodeling

Intervention

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.

Locations

Country	Name	City	State
France	CHu de Caen	Caen	Normandie

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Caen	Société Française de Cardiologie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of coronary endothelial function	3 months following an acute coronary syndrome STEMI an ST segment (segments in myocardial infarcted area and "remote" ) .	3 months
Primary	Measurement of fibrosis	3 months following an acute coronary syndrome STEMI an ST segment (segments in myocardial infarcted area and "remote" ) .	3 months
Secondary	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