Clinical trial NCT00529607: Diagnostics for the Reperfusion Injury Following MI
Official title: New Imaging and Diagnostic Techniques for the Assessment of Reperfusion Injury in Myocardial Infarction.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Reperfusion Injury
Keywords: myocardial infarction, reperfusion injury, echocardiography, magnetic resonance imaging, inflammation, nitric oxide
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2007-09-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * 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)

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Department of Medicine, Division of Cardiology, Pulmonary Diseases and Vascular Medicine at the University Hospital, RWTH Aachen
state: NRW
Study officials:
affiliation: Department of Medicine, Division of Cardiology, Pulmonary Diseases and Vascular Medicine at the University Hospital, RWTH Aachen
name: Wolfgang Lepper
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kehmeier ES, Lepper W, Kropp M, Heiss C, Hendgen-Cotta U, Balzer J, Neizel M, Meyer C, Merx MW, Verde PE, Ohmann C, Heusch G, Kelm M, Rassaf T. TNF-alpha, myocardial perfusion and function in patients with ST-segment elevation myocardial infarction and primary percutaneous coronary intervention. Clin Res Cardiol. 2012 Oct;101(10):815-27. doi: 10.1007/s00392-012-0465-x. Epub 2012 May 6.