Study Results
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Basic Information
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COMPLETED
486 participants
OBSERVATIONAL
2010-02-28
2013-04-30
Brief Summary
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An early identification of patients at risk for SAP allowing an early initiation of antiinfective therapy may improve the prognosis. To date, no reliable prediction models or clinical scores for stroke-associated pneumonia exist. Recently, it was shown that parameters indicating an impaired immune function are associated with the subsequent occurrence of SAP and could therefore be used as predictors for SAP.
This study will develop and prospectively validate a prognostic score to predict SAP based on clinical parameters. Furthermore, the study examines the prognostic properties of selected immune and infectious parameters for the prediction and diagnosis of SAP. The study will further address the question whether these infectious and immune parameters predict the 3-month-outcome. In a subgroup of patients, MRI parameters on stroke size and localization will be assessed to investigate whether these parameters might allow prediction of SAP or the 3-month-outcome.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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ischemic stroke patients
patients with an ischemic stroke in the anterior (ACA, MCA) and posterior flow area (PCA, BA) of any severity in the last 36h
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* stroke onset within the last 36h
* age ≥ 18
* consent by the patient or the legal representative
Exclusion Criteria
* signs of infection at admission (clinical / paraclinical)
* pre-existing dysphagia
* mechanical ventilation at admission
* participation in an interventional trial
18 Years
ALL
No
Sponsors
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Siemens Health Care
UNKNOWN
NeuroCure Clinical Research Center, Charite, Berlin
OTHER
Charite University, Berlin, Germany
OTHER
Responsible Party
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Andreas Meisel
Professor Dr. med.
Principal Investigators
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Andreas Meisel, MD
Role: PRINCIPAL_INVESTIGATOR
Charite University Berlin (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)
Peter Heuschmann, MD
Role: PRINCIPAL_INVESTIGATOR
Charité University Berlin (Center for Stroke Research Berlin CSB)
Locations
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Charite University (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)
Berlin, , Germany
Unfallkrankenhaus Berlin, Neurologie
Berlin, , Germany
Vivantes Auguste Viktoria Klinikum Neurologie
Berlin, , Germany
Vivantes Klinikum im Friedrichshain Neurologie
Berlin, , Germany
Vivantes Klinikum Spandau Neurologie
Berlin, , Germany
Vivantes Neukölln Neurologie
Berlin, , Germany
Sankt Josefs Krankenhaus Potsdam Neurologie
Potsdam, , Germany
Hospital Vall d'Hebron
Barcelona, , Spain
Countries
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References
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Hoffmann S, Harms H, Ulm L, Nabavi DG, Mackert BM, Schmehl I, Jungehulsing GJ, Montaner J, Bustamante A, Hermans M, Hamilton F, Gohler J, Malzahn U, Malsch C, Heuschmann PU, Meisel C, Meisel A; PREDICT Investigators. Stroke-induced immunodepression and dysphagia independently predict stroke-associated pneumonia - The PREDICT study. J Cereb Blood Flow Metab. 2017 Dec;37(12):3671-3682. doi: 10.1177/0271678X16671964. Epub 2016 Oct 14.
Hotter B, Hoffmann S, Ulm L, Meisel C, Bustamante A, Montaner J, Katan M, Smith CJ, Meisel A. External Validation of Five Scores to Predict Stroke-Associated Pneumonia and the Role of Selected Blood Biomarkers. Stroke. 2021 Jan;52(1):325-330. doi: 10.1161/STROKEAHA.120.031884. Epub 2020 Dec 7.
Hotter B, Hoffmann S, Ulm L, Meisel C, Fiebach JB, Meisel A. IL-6 Plasma Levels Correlate With Cerebral Perfusion Deficits and Infarct Sizes in Stroke Patients Without Associated Infections. Front Neurol. 2019 Feb 15;10:83. doi: 10.3389/fneur.2019.00083. eCollection 2019.
Hotter B, Hoffmann S, Ulm L, Montaner J, Bustamante A, Meisel C, Meisel A. Inflammatory and stress markers predicting pneumonia, outcome, and etiology in patients with stroke: Biomarkers for predicting pneumonia, functional outcome, and death after stroke. Neurol Neuroimmunol Neuroinflamm. 2020 Feb 25;7(3):e692. doi: 10.1212/NXI.0000000000000692. Print 2020 May.
Mengel A, Ulm L, Hotter B, Harms H, Piper SK, Grittner U, Montaner J, Meisel C, Meisel A, Hoffmann S. Biomarkers of immune capacity, infection and inflammation are associated with poor outcome and mortality after stroke - the PREDICT study. BMC Neurol. 2019 Jul 3;19(1):148. doi: 10.1186/s12883-019-1375-6.
Winek K, Lobentanzer S, Nadorp B, Dubnov S, Dames C, Jagdmann S, Moshitzky G, Hotter B, Meisel C, Greenberg DS, Shifman S, Klein J, Shenhar-Tsarfaty S, Meisel A, Soreq H. Transfer RNA fragments replace microRNA regulators of the cholinergic poststroke immune blockade. Proc Natl Acad Sci U S A. 2020 Dec 22;117(51):32606-32616. doi: 10.1073/pnas.2013542117. Epub 2020 Dec 7.
Other Identifiers
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PREDICT
Identifier Type: -
Identifier Source: org_study_id
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