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

Myocardial Infarction Clinical Trial

— R²ACE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01414452
• Other study ID #: UAntwerpen
• Status: Completed
• Phase: N/A
• First received: August 10, 2011
• Last updated: July 19, 2015
• Start date: April 2011
• Est. completion date: December 2013

Study information

• Verified date: July 2015
• Source: Universiteit Antwerpen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• STEMI treated with primary PCI

Exclusion Criteria:

• ischemia time >12h

• use of immunosuppressive therapy

• unsuccessful recanalisation

• not-interpretable ST-T segment

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Reperfusion Injury

Locations

Country	Name	City	State
Belgium	University hospital	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence of reperfusion injury after succesfull primary 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	No
Secondary	Major cardiovascular event rate	combined endpoint of hospitalisation (or extension of hospitalisation) for heart failure and cardiac death in a period of one year	at 1 year	Yes