Role of Adiponectin and Endothelial Progenitor Cells in Reperfusion Injury in Patients With Acute Myocardial Infarction (R²ACE)
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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 |
- 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
- 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
| Estimated Enrollment: | 250 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated 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 |
ST elevetion myocardial infarction patients
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| Contact: Marc J Claeys, MD, PhD | 3238214706 | marc.claeys@ua.ac.be |
| Belgium | |
| University hospital | Recruiting |
| Edegem, Antwerp, Belgium, 2650 | |
| Contact: Marc J Claeys, MD, PhD 3238214706 marc.claeys@ua.ac.be | |
| Sub-Investigator: Marc Ronsijn, Md | |
| Sub-Investigator: Chris Vrints, MD, PhD | |
More Information
No publications provided
| Responsible Party: | Prof Dr Marc Claeys, University hospital Antwerp: dept of cardiology |
| ClinicalTrials.gov Identifier: | NCT01414452 History of Changes |
| Other Study ID Numbers: | UAntwerpen |
| Study First Received: | August 10, 2011 |
| Last Updated: | August 10, 2011 |
| 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 Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Postoperative Complications |
ClinicalTrials.gov processed this record on May 19, 2013