Reperfusion InjuryNCT00529607
Diagnostics for the Reperfusion Injury Following MI
An observational study of Reperfusion Injury, run by RWTH Aachen University at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Reperfusion Injury
- What is being tested?
- contrast echocardiography, 2D and 3D echocardiography and cardiac MRI
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2007to Mar 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Medicine, Division of Cardiology, Pulmonary Diseases and Vascular Medicine at the University Hospital, RWTH Aachen
Aachen, North Rhine-Westphalia, 52074
About this study
Official title: 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.
Read the 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.
- Conditions
- Reperfusion Injury
- Being tested
- contrast echocardiography, 2D and 3D echocardiography, cardiac MRI, blood sampling
- Keywords
- myocardial infarction, reperfusion injury, echocardiography, magnetic resonance imaging, inflammation, nitric oxide
- Medical subject headings
- Reperfusion Injury, Myocardial Infarction, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contrast echocardiographyDrug
Also called with luminity or sonovue
directly after PCI, at 24 h after PCI, before discharge and at 6 months
2D and 3D echocardiographyProcedure or surgery
directly after PCI, at 24 h after PCI, before discharge and at 6 months
cardiac MRIProcedure or surgery
before discharge and after 6 months
blood samplingProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | - patients with acute ST elevation myocardial infarction and consecutive percutaneous coronary intervention of the infarct-related artery Receives: Drug: contrast echocardiography; Procedure: 2D and 3D echocardiography; Procedure: cardiac MRI; Procedure: blood sampling | |
| 2 | - 30 patients with stable CAD (control group 1) Receives: Procedure: blood sampling | |
| 3 | - 30 healthy volunteers regarding cardiovascular diseases (control group 2) Receives: Procedure: blood sampling |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Reperfusion InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Investigators
- Wolfgang Lepper, Principal investigator, Department of Medicine, Division of Cardiology, Pulmonary Diseases and Vascular Medicine at the University Hospital, RWTH Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00529607
- Sponsor's protocol ID
- IZKF BIOMAT Aachen TVB 119
- Status last verified
- Mar 2009
- First submitted
- 12 Sep 2007
- Last updated
- 20 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22562290
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Imaging and Diagnostic Techniques for the Assessment of Reperfusion Injury in Myocardial Infarction.
- ClinicalTrials.gov ID
- NCT00529607
- Acronym / sponsor ID
- IZKF BIOMAT Aachen TVB 119
- Conditions
- Reperfusion Injury
- Keywords
- myocardial infarction, reperfusion injury, echocardiography, magnetic resonance imaging, inflammation, nitric oxide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 14 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: contrast echocardiography, Procedure: 2D and 3D echocardiography, Procedure: cardiac MRI, Procedure: blood sampling- patients with acute ST elevation myocardial infarction and consecutive percutaneous coronary intervention of the infarct-related artery |
| 2 | – | Procedure: blood sampling- 30 patients with stable CAD (control group 1) |
| 3 | – | Procedure: blood sampling- 30 healthy volunteers regarding cardiovascular diseases (control group 2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- minors
- incompetent persons
- pregnant and lactating
- moderate to severe renal insufficiency defined by an GFR < 60 ml/kg/m2
- missing written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| contrast echocardiographyAlso: with luminity or sonovuedirectly after PCI, at 24 h after PCI, before discharge and at 6 months | Drug | 1 |
| 2D and 3D echocardiographydirectly after PCI, at 24 h after PCI, before discharge and at 6 months | Procedure or surgery | 1 |
| cardiac MRIbefore discharge and after 6 months | Procedure or surgery | 1 |
| blood samplingroutine 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 | Procedure or surgery | 1, 2, 3 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2009.
- Derived from this study: PubMed 22562290Kehmeier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang Lepper principal investigator
Department of Medicine, Division of Cardiology, Pulmonary Diseases and Vascular Medicine at the University Hospital, RWTH Aachen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reperfusion Injury, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00529607, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2009.