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| Name | Class |
|---|---|
| NeuroCure Clinical Research Center, Charite, Berlin | OTHER |
| Department of Nephrology and Internal Intensive Care Medicine, Charite, Berlin | UNKNOWN |
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This study explores the use of CRP level reduction in patients after suffering from acute ischemic stroke. Using selective CRP-apheresis, the investigators aim to reduce the secondary inflammatory tissue damage in the course of infarction maturation using infarction growth in MRI as the primary outcome as a surrogate.
C-reactive protein (CRP) is an acute-phase protein binding to phosphocholine, thereby marking damaged tissue. This in turn activates the complement system and the cellular immune system engaging the unspecific immune system in an inflammatory tissue-degrading reaction. Such a pattern is observed in ischemic stroke, and elevated CRP levels can be measured in stroke survivors' sera. Several observational studies reproduced higher CRP levels with negative outcome in stroke. In another vascular model disease, myocardial infarction, selective CRP apheresis reduced infarct size in humans. The investigators therefore designed this pilot study to explore the effects of selective CRP reduction in ischemic stroke patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRP apheresis | Experimental | CRP apheresis by means of selective apheresis using the "PentraSorb"-CRP adsorber |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRP apheresis | Device | selective CRP apheresis by use of the "PentraSorb"-CRP |
|
| Measure | Description | Time Frame |
|---|---|---|
| Infarct growth | Infarct growth measured via DWI-FLAIR volume change | 5 ± 1 days after infarction |
| Measure | Description | Time Frame |
|---|---|---|
| Infarct growth | Infarct growth measured via diffusion-weighted imaging (DWI)-FLAIR volume change | 90 ± 14 days after infarction |
| Stroke Severity | National Institute of Health Stroke Scale (NIHSS) score - ranging from 0-42 - higher values represent a worse outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Benjamin Hotter, Dr. med. | Contact | +49 30 450 639729 | benjamin.hotter@charite.de | |
| Andreas Meisel, Prof. Dr. med. | Contact | +49 30 450 560026 | andreas.meisel@charite.de |
| Name | Affiliation | Role |
|---|---|---|
| Andreas Meisel, Prof. Dr. med. | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zentrum für Schlaganfallforschung (CSB) / Klinik für Neurologie mit Experimenteller Neurologie der Charité | Recruiting | Berlin | 12200 | Germany |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Comparisons will be drawn from historic controls from previous observational stroke studies
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| 5 ± 1 days after infarction |
| Functional Outcome | Modified ranking scale (mRS) score - ranging from 0-6 with higher scores signifying worse outcome no subscales | 90 ± 14 days after infarction |
| Dependency | Barthel Index (BI) - ranging from 0-100 with higher scores signifying better outcome; no subscales | 90 ± 14 days after infarction |
| Cognitive Impairment | Montreal Cognitive Assessment (MoCA) - ranging from 0-30 with higher scores signifying better outcome; no subscales | 90 ± 14 days after infarction |
| Quality of Life after Stroke via Stroke Impact Scale (SIS) | Stroke Impact Scale - Stroke Impact Scale (SIS) - measures different aspects of the overall impact of stroke on the patients' health and quality of life with different subscales addressing different domains:
| 90 ± 14 days after infarction |
| Incidence of Complications | Composite frequency of Complications within the time frame | 90 ± 14 days after infarction |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |