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

Sponsor
Universiteit Antwerpen (Other)
Overall Status
Completed
CT.gov ID
NCT01414452
Collaborator
(none)
250
Enrollment
1
Location
32
Duration (Months)
7.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    250 participants
    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
    Study Start Date :
    Apr 1, 2011
    Actual Primary Completion Date :
    Dec 1, 2012
    Actual Study Completion Date :
    Dec 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    STEMI patients

    Patients with ST elevation myocardial infarction,lasting <12 hour, who were succesfully treated with primary PCI

    Outcome Measures

    Primary Outcome Measures

    1. occurrence of reperfusion injury after succesfull primary PCI [within 90 min after PCI]

      Serial ECG measurements (before and after PCI to assess extent of ST segment resolution as marker of reperfusion injury

    Secondary Outcome Measures

    1. Major cardiovascular event rate [at 1 year]

      combined endpoint of hospitalisation (or extension of hospitalisation) for heart failure and cardiac death in a period of one year

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 University hospital Edegem Antwerp Belgium 2650

    Sponsors and Collaborators

    • Universiteit Antwerpen

    Investigators

    • Principal Investigator: Marc Claeys, MD PHD, University Hospital, Antwerp

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    M Claeys, Prof dr, Universiteit Antwerpen
    ClinicalTrials.gov Identifier:
    NCT01414452
    Other Study ID Numbers:
    • UAntwerpen
    First Posted:
    Aug 11, 2011
    Last Update Posted:
    Jul 21, 2015
    Last Verified:
    Jul 1, 2015
    Keywords provided by M Claeys, Prof dr, Universiteit Antwerpen
    Myocardial Infarction
    Reperfusion injury
    Adiponectin
    endothelial progenitor cells
    Additional relevant MeSH terms:
    Myocardial Infarction
    Reperfusion Injury
    Infarction
    Wounds and Injuries

    Study Results

    No Results Posted as of Jul 21, 2015