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

July 19, 2015 updated by: M Claeys, Universiteit Antwerpen

Reperfusion Injury and Cardiac Remodelling After Myocardial Infarction in Relation to Adiponectin Level, Circulating Endothelial Progenitor Cells and Endothelial Microparticles

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
    • Antwerp
      • Edegem, Antwerp, Belgium, 2650
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

ST elevetion myocardial infarction patients

Description

Inclusion Criteria:

  • STEMI treated with primary PCI

Exclusion Criteria:

  • ischemia time >12h
  • use of immunosuppressive therapy
  • unsuccessful recanalisation
  • not-interpretable ST-T segment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within 90 min after PCI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiteit Antwerpen

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

August 10, 2011

First Submitted That Met QC Criteria

August 10, 2011

First Posted (Estimate)

August 11, 2011

Study Record Updates

Last Update Posted (Estimate)

July 21, 2015

Last Update Submitted That Met QC Criteria

July 19, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UAntwerpen

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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