NCT02789098

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2016

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

6.2 years

First QC Date

April 21, 2016

Last Update Submit

March 8, 2022

Conditions

ST Elevation Myocardial Infarction

Keywords

ST Elevation Myocardial InfarctionVentricular remodelingBiomarkersCoronary endothelial functionPositron Emission Tomography

Outcome Measures

Primary Outcomes (2)

  • 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

  • Measurement of fibrosis

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

    3 months

Secondary Outcomes (1)

  • 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

Study Arms (1)

STEMI

OTHER

All patients included in this study (1 arm)

Other: (15)-O water positron emission tomography and Biomarkers

Interventions

(15)-O water positron emission tomography and BiomarkersOTHER

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.

STEMI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHu de Caen

Caen, Normandy, 14000, France

Location

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionVentricular Remodeling

Interventions

Biomarkers

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisPathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Biological Factors

Study Officials

  • Farzin GF BEYGUI, PhD

    CHU CAEN

    STUDY CHAIR

  • Alain MA Manrique, PhD

    CHU CAEN

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2016

First Posted

June 2, 2016

Study Start

June 1, 2016

Primary Completion

August 1, 2022

Study Completion

March 1, 2023

Last Updated

March 22, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)