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| Sponsored by: |
RWTH Aachen University |
|---|---|
| Information provided by: | RWTH Aachen University |
| ClinicalTrials.gov Identifier: | NCT00529607 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Reperfusion Injury |
Drug: contrast echocardiography Procedure: 2D and 3D echocardiography Procedure: cardiac MRI Procedure: blood sampling |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | New Imaging and Diagnostic Techniques for the Assessment of Reperfusion Injury in Myocardial Infarction. |
Biomarkers for Infarction and Inflammation
| Estimated Enrollment: | 200 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | January 2010 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
- patients with acute ST elevation myocardial infarction and consecutive percutaneous coronary intervention of the infarct-related artery
|
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
Procedure: cardiac MRI
before discharge and after 6 months
Procedure: 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 |
|
2
- 30 patients with stable CAD (control group 1)
|
Procedure: 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 |
|
3
- 30 healthy volunteers regarding cardiovascular diseases (control group 2)
|
Procedure: 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 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
or 30 patients with stable CAD (control group 1) or 30 healthy volunteers regarding cardiovascular diseases (control group 2)
Inclusion Criteria:
or 30 patients with stable CAD (control group 1) or 30 healthy volunteers regarding cardiovascular diseases (control group 2)
Exclusion Criteria:
Contacts and Locations| Contact: Wolfgang Lepper, MD | +49 241 80 89 831 | wlepper@ukaachen.de |
| Germany, NRW | |
| Department of Medicine, Division of Cardiology, Pulmonary Diseases and Vascular Medicine at the University Hospital, RWTH Aachen | Recruiting |
| Aachen, NRW, Germany, 52074 | |
| Contact: Wolfgang Lepper, MD +49 241 80 89 831 wlepper@ukaachen.de | |
| Principal Investigator: | Wolfgang Lepper | Department of Medicine, Division of Cardiology, Pulmonary Diseases and Vascular Medicine at the University Hospital, RWTH Aachen |
More Information
| Responsible Party: | Medical Clinic I and IZKF Biomat ( RWTH Aachen University ) |
| Study ID Numbers: | IZKF BIOMAT Aachen TVB 119 |
| Study First Received: | September 12, 2007 |
| Last Updated: | September 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00529607 |
| Health Authority: | Germany: Ethics Commission |
|
myocardial infarction, reperfusion injury, echocardiography, magnetic resonance imaging, inflammation, nitric oxide |
|
Nitric Oxide Heart Diseases Postoperative Complications Myocardial Ischemia Vascular Diseases |
Ischemia Infarction Myocardial Infarction Inflammation Reperfusion Injury |
|
Pathologic Processes Cardiovascular Diseases |
