Diagnostics for the Reperfusion Injury Following MI
March 19, 2009 updated by: RWTH Aachen University
New Imaging and Diagnostic Techniques for the Assessment of Reperfusion Injury in Myocardial Infarction.
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
NRW
-
Aachen, NRW, Germany, 52074
- Department of Medicine, Division of Cardiology, Pulmonary Diseases and Vascular Medicine at the University Hospital, RWTH Aachen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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)
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1
- patients with acute ST elevation myocardial infarction and consecutive percutaneous coronary intervention of the infarct-related artery
|
directly after PCI, at 24 h after PCI, before discharge and at 6 months
Other Names:
directly after PCI, at 24 h after PCI, before discharge and at 6 months
before discharge and after 6 months
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)
|
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)
|
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 |
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Wolfgang Lepper, Department of Medicine, Division of Cardiology, Pulmonary Diseases and Vascular Medicine at the University Hospital, RWTH Aachen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
September 12, 2007
First Submitted That Met QC Criteria
September 12, 2007
First Posted (Estimate)
September 14, 2007
Study Record Updates
Last Update Posted (Estimate)
March 20, 2009
Last Update Submitted That Met QC Criteria
March 19, 2009
Last Verified
March 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IZKF BIOMAT Aachen TVB 119
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.