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Prediction of Stroke-associated Pneumonia (PREDICT)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Siemens Health Care
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01079728
First received: March 2, 2010
Last updated: February 19, 2013
Last verified: February 2013
History of Changes

March 2, 2010
February 19, 2013
February 2010
December 2012   (final data collection date for primary outcome measure)
  • Predictive score for SAP based on clinical parameters assessed within 36h after stroke onset [ Time Frame: SAP within 7 days after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    To establish a predictive score for SAP based on clinical parameters assessed within 36h after stroke onset
  • Predictive properties of immune parameters (IL6, IL10, mHLA-DR) or infection parameters (PCT) for the occurrence of a SAP within 7 days after stroke onset [ Time Frame: SAP within 7 days after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    To evaluate of the predictive properties of immune parameters (IL6, IL10, mHLA-DR) or infection parameters (PCT) for the occurrence of a SAP within 7 days after stroke onset
  • base score for the prediction of a SAP [ Time Frame: within 7 days after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    development of a base score for the prediction of a SAP (based on clinical parameters)
  • predictive qualities of immune and infection parameters for the occurence of a SAP [ Time Frame: within 7 days after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    evaluation of the predictive qualities of immune parameters (IL6, IL10, mHLA-DR) or infection parameters (PCT) for the occurrence of a SAP
Complete list of historical versions of study NCT01079728 on ClinicalTrials.gov Archive Site
  • Predictive properties of immune parameters (IL6, IL8, IL10, mHLA-DR, MBL, monocytic cytokine secretion after ex vivo stimulation, C5a) and infection parameters (PCT, LBP) for the neurological outcome [ Time Frame: Neurological outcome 3 months after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    To evaluate of the predictive properties of immune parameters (IL6, IL8, IL10, mHLA-DR, MBL, monocytic cytokine secretion after ex vivo stimulation, C5a) and infection parameters (PCT, LBP) for the neurological outcome
  • Plasma levels of acetylcholinesterase [ Time Frame: within 7 days after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    To investigate the parasympathetic influence on the immune function after stroke by measuring plasma levels of acetylcholinesterase
  • Localization and stroke volume analysis [ Time Frame: SAP within 7 days and neurological outcome after 3 months after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    To investigate the influence of the localization and stroke volume on the occurrence of a SAP and on neurological outcome
  • Predictive properties of immune parameters (IL6, IL8, IL10, mHLA-DR, MBL, monocytic cytokine secretion after ex vivo stimulation, C5a) and infection parameters (PCT, LBP) for the occurence of a SAP [ Time Frame: SAP within 7 days after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    To evaluate of the predictive properties of immune parameters (IL6, IL8, IL10, mHLA-DR, MBL, monocytic cytokine secretion after ex vivo stimulation, C5a) and infection parameters (PCT, LBP) for the occurence of a SAP
  • Influence of insular cortex involvement and infarct volume on the occurrence of a SAP within 7 days and and on the neurological outcome after 3 months [ Time Frame: SAP within 7 days after onset of symptoms (stroke) and neurological outcome after 3 months ] [ Designated as safety issue: No ]
    To investigate the influence of insular cortex involvement and infarct volume on the occurrence of a SAP within 7 days after stroke onset and on the neurological outcome after 3 months
  • Transcriptome analyses [ Time Frame: SAP within 7 days and neurological outcome after 3 months after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    To perform transcriptome analyses to identify new biomarkers which may predict the occurence of a SAP or the 3-month neurological outcome
  • predictive qualities of immune and infection parameters for the neurological outcome [ Time Frame: 90 days after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    evaluation of the predictive qualities of immune parameters (IL6, IL8, IL10, mHLA-DR, MBL, monocytic cytokine secretion after ex vivo stimulation, C5a) and infection parameters (PCT, LBP) for the neurological outcome
  • plasma levels of acetylcholinesterase [ Time Frame: within 7 days after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    investigation of the parasympathetic influence on the immune function after stroke by measuring plasma levels of acetylcholinesterase
  • ischemic lesion of the island region and infarct volume [ Time Frame: within 7 days and 90 days after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
    investigation of the influence of an ischemic lesion of the island region and infarct volume on the occurrence of a SAP within 7 days after onset of symptoms of stroke and on the neurological outcome after 3 months
Not Provided
Not Provided
 
Prediction of Stroke-associated Pneumonia
Prediction of Stroke-associated Pneumonia

Stroke-associated pneumonia (SAP) constitutes a clinically relevant complication of stroke, because it increases the mortality and has a negative impact on the neurological prognosis of the patient.

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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Blood sample (serum, plasma)
Probability Sample

ischemic stroke in the anterior (ACA, MCA) and posterior cerebral circulation (PCA, BA) of any severity in the last 36h
Ischemic Stroke
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
486
March 2013
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • ischemic stroke in the anterior (ACA, MCA) and posterior cerebral circulation (PCA, BA) of any severity
  • stroke onset within the last 36h
  • age ≥ 18
  • consent by the patient or the legal representative

Exclusion Criteria:

  • intracranial hemorrhage
  • signs of infection at admission (clinical / paraclinical)
  • pre-existing dysphagia
  • mechanical ventilation at admission
  • participation in an interventional trial
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Spain
 
NCT01079728
PREDICT
No
Prof. Dr. Andreas Meisel, Charite University, Berlin, Germany (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)
Charite University, Berlin, Germany
Siemens Health Care
Principal Investigator: Andreas Meisel, MD Charite University Berlin (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)
Principal Investigator: Peter Heuschmann, MD Charité University Berlin (Center for Stroke Research Berlin CSB)
Charite University, Berlin, Germany
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP