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

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ClinicalTrials.gov Identifier: NCT01414452
Recruitment Status : Completed
First Posted : August 11, 2011
Last Update Posted : July 21, 2015
Sponsor:
Information provided by (Responsible Party):
M Claeys, Universiteit Antwerpen

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
Myocardial Infarction Reperfusion Injury

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 : April 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Group/Cohort
STEMI patients
Patients with ST elevation myocardial infarction,lasting <12 hour, who were succesfully treated with primary PCI



Primary Outcome Measures :
  1. occurrence of reperfusion injury after succesfull primary PCI [ Time Frame: 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 [ Time Frame: at 1 year ]
    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


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01414452


Locations
Belgium
University hospital
Edegem, Antwerp, Belgium, 2650
Sponsors and Collaborators
Universiteit Antwerpen
Investigators
Principal Investigator: Marc Claeys, MD PHD University Hospital, Antwerp

Responsible Party: M Claeys, Prof dr, Universiteit Antwerpen
ClinicalTrials.gov Identifier: NCT01414452     History of Changes
Other Study ID Numbers: UAntwerpen
First Posted: August 11, 2011    Key Record Dates
Last Update Posted: July 21, 2015
Last Verified: July 2015

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

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