Diagnostics for the Reperfusion Injury Following MI

Completed

• Conditions: Reperfusion Injury
• Interventions: Procedure: blood sampling; Drug: contrast echocardiography; Procedure: 2D and 3D echocardiography; Procedure: cardiac MRI

• Registration Number: NCT00529607
• Lead Sponsor: RWTH Aachen University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-12
• Study First Submitted QC: 2007-09-12
• Study First Posted: 2007-09-14
• Status Verified: 2009-03
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Last Update Submitted: 2009-03-19
• Last Update Posted: 2009-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
3	blood sampling	- 30 healthy volunteers regarding cardiovascular diseases (control group 2)
1	blood sampling	- patients with acute ST elevation myocardial infarction and consecutive percutaneous coronary intervention of the infarct-related artery
1	contrast echocardiography	- patients with acute ST elevation myocardial infarction and consecutive percutaneous coronary intervention of the infarct-related artery
1	2D and 3D echocardiography	- patients with acute ST elevation myocardial infarction and consecutive percutaneous coronary intervention of the infarct-related artery
2	blood sampling	- 30 patients with stable CAD (control group 1)
1	cardiac MRI	- patients with acute ST elevation myocardial infarction and consecutive percutaneous coronary intervention of the infarct-related artery

Trial Locations

Locations (1)

Department of Medicine, Division of Cardiology, Pulmonary Diseases and Vascular Medicine at the University Hospital, RWTH Aachen; 🇩🇪 Aachen, NRW, Germany