Diagnostics for the Reperfusion Injury Following MI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2009-03-31

Brief Summary

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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.

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Detailed Description

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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

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Reperfusion Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

\- patients with acute ST elevation myocardial infarction and consecutive percutaneous coronary intervention of the infarct-related artery

contrast echocardiography

Intervention Type DRUG

directly after PCI, at 24 h after PCI, before discharge and at 6 months

2D and 3D echocardiography

Intervention Type PROCEDURE

directly after PCI, at 24 h after PCI, before discharge and at 6 months

cardiac MRI

Intervention Type PROCEDURE

before discharge and after 6 months

blood sampling

Intervention Type PROCEDURE

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)

blood sampling

Intervention Type PROCEDURE

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)

blood sampling

Intervention Type PROCEDURE

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

Interventions

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contrast echocardiography

directly after PCI, at 24 h after PCI, before discharge and at 6 months

Intervention Type DRUG

2D and 3D echocardiography

directly after PCI, at 24 h after PCI, before discharge and at 6 months

Intervention Type PROCEDURE

cardiac MRI

before discharge and after 6 months

Intervention Type 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

Intervention Type PROCEDURE

Other Intervention Names

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with luminity or sonovue

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes