Diagnostics for the Reperfusion Injury Following MI

Reperfusion Injury Clinical Trial

Official title:

New Imaging and Diagnostic Techniques for the Assessment of Reperfusion Injury in Myocardial Infarction.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00529607
• Other study ID #: IZKF BIOMAT Aachen TVB 119
• Status: Completed
• Phase: N/A
• First received: September 12, 2007
• Last updated: March 19, 2009
• Start date: September 2007
• Est. completion date: March 2009

Study information

• Verified date: March 2009
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

The primary purpose of this study is to correlate new cardiac imaging modalities (2D, 3D echocardiography, contrast echocardiography, strain analysis and cardiac MRI) to biochemical parameters as the L-arginine-nitric oxide pathway and inflammatory cascades to characterize the reperfusion injury following myocardial infarction and thus providing a basis for further diagnostic and therapeutic approaches.

Description:

By reperfusion of ischemic myocardium further tissue damage occurs (ischemia / reperfusion injury). Various contributing mechanisms have been discussed in experimental studies, e.g. disturbances in coronary microcirculation and consecutive induction of inflammatory cascades involving formation of reactive oxygen species. The ischemia / reperfusion injury causes diastolic and regional as well as global systolic dysfunction. The time course of the reperfusion injury within the first hours after reperfusion and its effects on the global geometry of the left ventricle have not been investigated so far. In the present study a comprehensive morphological and functional characterisation of the ischemia / reperfusion injury in the acute phase is performed. New cardiac imaging modalities (2D, 3D echocardiography, contrast echocardiography, strain analysis and cardiac MRI)and biochemical parameters including the L-arginine-nitric oxide pathway and inflammatory cascades are applied. Hereby morphological and biochemical markers for the functional recovery of myocardial function should be identified.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with acute ST elevation myocardial infarction and consecutive percutaneous coronary intervention of the infarct-related artery (first myocardial infarction and recurrent myocardial infarction, as long as infarct-related artery is occluded for the first time)

• written informed consent

or 30 patients with stable CAD (control group 1) or 30 healthy volunteers regarding cardiovascular diseases (control group 2)

Exclusion Criteria:

• minors

• incompetent persons

• pregnant and lactating

• moderate to severe renal insufficiency defined by an GFR < 60 ml/kg/m2

• missing written consent

• other reasons complicating a clinical reevaluation and/or coronary angiography

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Myocardial Infarction
• Reperfusion Injury

Intervention

Drug:
• contrast echocardiography
directly after PCI, at 24 h after PCI, before discharge and at 6 months

Procedure:
• 2D and 3D echocardiography
directly after PCI, at 24 h after PCI, before discharge and at 6 months
• cardiac MRI
before discharge and after 6 months
• blood sampling
routine lab work plus infarction and inflammation biomarkers 1: before PCI, after PCI, at 34 hours, at discharge, at 6 months 2 and 3: one blood sample in total before PCI in 2 and at any time in 3

Locations

Country	Name	City	State
Germany	Department of Medicine, Division of Cardiology, Pulmonary Diseases and Vascular Medicine at the University Hospital, RWTH Aachen	Aachen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany,