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Ischemic StrokePREDICTNCT01079728

Prediction of Stroke-associated Pneumonia

An observational study of Ischemic Stroke, run by Charite University, Berlin, Germany at 8 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Stroke
How many people
486 participants
Where
8 sitesin 2 countries
Study dates
Feb 2010to Apr 2013
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
  • No healthy volunteers
  • Adult, Older adult

Study population: ischemic stroke in the anterior (ACA, MCA) and posterior cerebral circulation (PCA, BA) of any severity in the last 36h

Who may be able to join

  • 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

Who cannot join

  • intracranial hemorrhage
  • signs of infection at admission (clinical / paraclinical)
  • pre-existing dysphagia
  • mechanical ventilation at admission
  • participation in an interventional trial

Trial locations and contacts

8 sites in 2 countries.

8 sites in 2 countries

Germany7 sites

  • Charite University (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)

    Berlin, 10117

  • Unfallkrankenhaus Berlin, Neurologie

    Berlin

  • Vivantes Auguste Viktoria Klinikum Neurologie

    Berlin

  • Vivantes Klinikum im Friedrichshain Neurologie

    Berlin

  • Vivantes Klinikum Spandau Neurologie

    Berlin

  • Vivantes Neukölln Neurologie

    Berlin

  • Sankt Josefs Krankenhaus Potsdam Neurologie

    Potsdam

Other trials in Germany

Spain1 site

  • Hospital Vall d'Hebron

    Barcelona

Other trials in Spain

About this study

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.

Conditions
Ischemic Stroke
Keywords
ischemic stroke, stroke-associated pneumonia, prediction, immune and infection parameters
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01079728
Study groupRoleWhat they receive
ischemic stroke patientspatients with an ischemic stroke in the anterior (ACA, MCA) and posterior flow area (PCA, BA) of any severity in the last 36h

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Predictive score for SAP based on clinical parameters assessed within 36h after stroke onset

    To establish a predictive score for SAP based on clinical parameters assessed within 36h after stroke onset

    Measured: SAP within 7 days after onset of symptoms (stroke)

  2. 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

    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

    Measured: SAP within 7 days after onset of symptoms (stroke)

Secondary outcomes (6)

  1. 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

    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

    Measured: Neurological outcome 3 months after onset of symptoms (stroke)

  2. Plasma levels of acetylcholinesterase

    To investigate the parasympathetic influence on the immune function after stroke by measuring plasma levels of acetylcholinesterase

    Measured: within 7 days after onset of symptoms (stroke)

  3. Localization and stroke volume analysis

    To investigate the influence of the localization and stroke volume on the occurrence of a SAP and on neurological outcome

    Measured: SAP within 7 days and neurological outcome after 3 months after onset of symptoms (stroke)

  4. 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

    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

    Measured: SAP within 7 days after onset of symptoms (stroke)

  5. 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

    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

    Measured: SAP within 7 days after onset of symptoms (stroke) and neurological outcome after 3 months

  6. Transcriptome analyses

    To perform transcriptome analyses to identify new biomarkers which may predict the occurence of a SAP or the 3-month neurological outcome

    Measured: SAP within 7 days and neurological outcome after 3 months after onset of symptoms (stroke)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2010 (estimated)
  2. Study startFeb 2010
  3. Primary completionJan 2013
  4. Study completionApr 2013

Resources

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
Case only
Time perspective
Prospective
Enrolment
486 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01079728
Sponsor's protocol ID
PREDICT
Acronym
PREDICT
Status last verified
Dec 2021
First submitted
2 Mar 2010
Last updated
4 Jan 2022
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 27733675

  • 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.

    PubMed 33280547

  • 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.

    PubMed 30828313

  • 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.

    PubMed 32098866

  • 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.

    PubMed 31269910

  • 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.

    PubMed 33288717

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Stroke, run by Charite University, Berlin, Germany at 8 sites in 2 countries.

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 4 inclusion and 5 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 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Germany, Spain. 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.

What does the 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01079728, which also lists 6 linked publications.

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 4 Jan 2022.

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