Role of Adiponectin and Endothelial Progenitor Cells in Reperfusion Injury in Patients With Acute Myocardial Infarction (R²ACE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M Claeys, Universiteit Antwerpen
ClinicalTrials.gov Identifier:
NCT01414452
First received: August 10, 2011
Last updated: March 15, 2014
Last verified: March 2014
  Purpose

There is experimental evidence that low levels of adiponectin are associated with more reperfusion injury. In addition experimental studies have demonstrated that endothelial progenitor cells may have a favorable effect on remodeling, mainly through stimulation of neo-revascularisation. Clinical data on these issues are lacking. This clinical project studies the role of adiponectin, endothelial progenitor cells and endothelial microparticles in the ischaemia-reperfusion process and the compensatory ventricular remodelling in a population of 250 infarction patients treated with primary PCI. If the role of these factors could be confirmed in this clinical setting, those factors might represent a new target for therapeutic interventions in AMI patients.


Condition
Myocardial Infarction
Reperfusion Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Reperfusion Injury and Cardiac Remodelling After Myocardial Infarction in Relation to Adiponectin Level, Circulating Endothelial Progenitor Cells and Endothelial Microparticles

Resource links provided by NLM:


Further study details as provided by Universiteit Antwerpen:

Primary Outcome Measures:
  • occurrence of reperfusion injury after succesfull primary PCI [ Time Frame: within 90 min after PCI ] [ Designated as safety issue: No ]
    Serial ECG measurements (before and after PCI to assess extent of ST segment resolution as marker of reperfusion injury


Secondary Outcome Measures:
  • Major cardiovascular event rate [ Time Frame: at 1 year ] [ Designated as safety issue: Yes ]
    combined endpoint of hospitalisation (or extension of hospitalisation) for heart failure and cardiac death in a period of one year


Biospecimen Retention:   Samples Without DNA

blood samples


Enrollment: 250
Study Start Date: April 2011
Study Completion Date: December 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
STEMI patients
Patients with ST elevation myocardial infarction,lasting <12 hour, who were succesfully treated with primary PCI

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

ST elevetion myocardial infarction patients

Criteria

Inclusion Criteria:

  • STEMI treated with primary PCI

Exclusion Criteria:

  • ischemia time >12h
  • use of immunosuppressive therapy
  • unsuccessful recanalisation
  • not-interpretable ST-T segment
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01414452

Locations
Belgium
University hospital
Edegem, Antwerp, Belgium, 2650
Sponsors and Collaborators
Universiteit Antwerpen
  More Information

No publications provided

Responsible Party: M Claeys, Prof dr, Universiteit Antwerpen
ClinicalTrials.gov Identifier: NCT01414452     History of Changes
Other Study ID Numbers: UAntwerpen
Study First Received: August 10, 2011
Last Updated: March 15, 2014
Health Authority: Belgium: Institutional Review Board

Keywords provided by Universiteit Antwerpen:
Myocardial Infarction
Reperfusion injury
Adiponectin
endothelial progenitor cells

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Reperfusion Injury
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Postoperative Complications
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014