Acute Ischemic StrokePRECASTNCT00906542
Predictors of Early Chest Infection in Acute Ischemic Stroke
An observational study of Acute Ischemic Stroke and Pneumonia, run by University of Rostock at 1 site in Germany.
Trial summary
Pneumonia is a frequent complication of acute stroke and is associated with increased mortality and long-term impairment in the affected subjects. In previous studies, a number of clinical (e.g., dysphagia, severe neurological impairment, mechanical ventilation), radiological (e.g., large infarctions in the territory… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Pneumonia
- How many people
- 530 participants
- Where
- 1 siteGermany
- Study dates
- May 2009to Feb 2010
- 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: Acute ischemic stroke patients admitted to the neurological intensive care unit or stroke unit within 24 hours after stroke onset
Who may be able to join
- acute ischemic stroke
- admission to the neurological intensive care unit or stroke unit within 24 hours after stroke onset
- clearly assessed brain lesion location
Who cannot join
- previous large (non-lacunar) stroke
- chest infection present already on hospital admission
- mechanical ventilation already on day 1 or 2 after hospital admission
- treatment with immunosuppressive drugs
Trial locations and contacts
1 site in 1 country.
About this study
Pneumonia is a frequent complication of acute stroke and is associated with increased mortality and long-term impairment in the affected subjects. In previous studies, a number of clinical (e.g., dysphagia, severe neurological impairment, mechanical ventilation), radiological (e.g., large infarctions in the territory of middle cerebral artery, insular infarction) and biochemical (e.g., increased serum levels of C-reactive protein, decreased levels of CD4+ T-lymphocytes) findings have been reported as risk factors of stroke-related chest infection. The present study (PRECAST) aims to identify a small set out of these previously described risk factors that can predict stroke-related pneumonia with high sensitivity and specificity.
- Conditions
- Acute Ischemic Stroke, Pneumonia
- Keywords
- acute stroke, ischemic stroke, pneumonia, chest infection, brain lesion, lesion topology, dysphagia, sympathetic activation, immunosuppression
- Medical subject headings
- Ischemic Stroke, Pneumonia, Stroke, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute ischemic stroke patients | Acute ischemic stroke patients admitted to the neurological intensive care unit or stroke unit within 24 hours after stroke onset in whom ischemic brain lesion was clearly assessed on CT and/or MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnosis of chest infection within 7 days after stroke
Measured: days 1-7 after stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startMay 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 530 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rostock
- Sponsor type
- University, hospital or other
- Investigators
- Uwe Walter, MD, Study chair, University of Rostock, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906542
- Sponsor's protocol ID
- PRECAST-01
- Acronym
- PRECAST
- Status last verified
- Feb 2010
- First submitted
- 20 May 2009
- Last updated
- 19 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Prass K, Meisel C, Hoflich C, Braun J, Halle E, Wolf T, Ruscher K, Victorov IV, Priller J, Dirnagl U, Volk HD, Meisel A. Stroke-induced immunodeficiency promotes spontaneous bacterial infections and is mediated by sympathetic activation reversal by poststroke T helper cell type 1-like immunostimulation. J Exp Med. 2003 Sep 1;198(5):725-36. doi: 10.1084/jem.20021098. Epub 2003 Aug 25.
PubMed 12939340Chamorro A, Amaro S, Vargas M, Obach V, Cervera A, Torres F, Planas AM. Interleukin 10, monocytes and increased risk of early infection in ischaemic stroke. J Neurol Neurosurg Psychiatry. 2006 Nov;77(11):1279-81. doi: 10.1136/jnnp.2006.100800.
PubMed 17043295Chamorro A, Amaro S, Vargas M, Obach V, Cervera A, Gomez-Choco M, Torres F, Planas AM. Catecholamines, infection, and death in acute ischemic stroke. J Neurol Sci. 2007 Jan 15;252(1):29-35. doi: 10.1016/j.jns.2006.10.001. Epub 2006 Nov 28.
PubMed 17129587Walter U, Knoblich R, Steinhagen V, Donat M, Benecke R, Kloth A. Predictors of pneumonia in acute stroke patients admitted to a neurological intensive care unit. J Neurol. 2007 Oct;254(10):1323-9. doi: 10.1007/s00415-007-0520-0. Epub 2007 Mar 14.
PubMed 17361338Vogelgesang A, Grunwald U, Langner S, Jack R, Broker BM, Kessler C, Dressel A. Analysis of lymphocyte subsets in patients with stroke and their influence on infection after stroke. Stroke. 2008 Jan;39(1):237-41. doi: 10.1161/STROKEAHA.107.493635. Epub 2007 Nov 29.
PubMed 18048864Steinhagen V, Grossmann A, Benecke R, Walter U. Swallowing disturbance pattern relates to brain lesion location in acute stroke patients. Stroke. 2009 May;40(5):1903-6. doi: 10.1161/STROKEAHA.108.535468. Epub 2009 Mar 12.
PubMed 19286597
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Early Chest Infection in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT00906542
- Acronym / sponsor ID
- PRECAST / PRECAST-01
- Conditions
- Acute Ischemic Stroke, Pneumonia
- Keywords
- acute stroke, ischemic stroke, pneumonia, chest infection, brain lesion, lesion topology, dysphagia, sympathetic activation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 530 participants (actual)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 21 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pneumonia is a frequent complication of acute stroke and is associated with increased mortality and long-term impairment in the affected subjects. In previous studies, a number of clinical (e.g., dysphagia, severe neurological impairment, mechanical ventilation), radiological (e.g., large infarctions in the territory of middle cerebral artery, insular infarction) and biochemical (e.g., increased serum levels of C-reactive protein, decreased levels of CD4+ T-lymphocytes) findings have been reported as risk factors of stroke-related chest infection. The present study (PRECAST) aims to identify a small set out of these previously described risk factors that can predict stroke-related pneumonia with high sensitivity and specificity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute ischemic stroke patients | – | –Acute ischemic stroke patients admitted to the neurological intensive care unit or stroke unit within 24 hours after stroke onset in whom ischemic brain lesion was clearly assessed on CT and/or MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute ischemic stroke patients admitted to the neurological intensive care unit or stroke unit within 24 hours after stroke onset
Key inclusion criteria (3 listed)
- acute ischemic stroke
- admission to the neurological intensive care unit or stroke unit within 24 hours after stroke onset
- clearly assessed brain lesion location
Key exclusion criteria (4 listed)
- previous large (non-lacunar) stroke
- chest infection present already on hospital admission
- mechanical ventilation already on day 1 or 2 after hospital admission
- treatment with immunosuppressive drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
diagnosis of chest infection within 7 days after stroke
Time frame: days 1-7 after stroke
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2010.
- Background: PubMed 12939340Prass K, Meisel C, Hoflich C, Braun J, Halle E, Wolf T, Ruscher K, Victorov IV, Priller J, Dirnagl U, Volk HD, Meisel A. Stroke-induced immunodeficiency promotes spontaneous bacterial infections and is mediated by sympathetic activation reversal by poststroke T helper cell type 1-like immunostimulation. J Exp Med. 2003 Sep 1;198(5):725-36. doi: 10.1084/jem.20021098. Epub 2003 Aug 25.
- Background: PubMed 17043295Chamorro A, Amaro S, Vargas M, Obach V, Cervera A, Torres F, Planas AM. Interleukin 10, monocytes and increased risk of early infection in ischaemic stroke. J Neurol Neurosurg Psychiatry. 2006 Nov;77(11):1279-81. doi: 10.1136/jnnp.2006.100800.
- Background: PubMed 17129587Chamorro A, Amaro S, Vargas M, Obach V, Cervera A, Gomez-Choco M, Torres F, Planas AM. Catecholamines, infection, and death in acute ischemic stroke. J Neurol Sci. 2007 Jan 15;252(1):29-35. doi: 10.1016/j.jns.2006.10.001. Epub 2006 Nov 28.
- Background: PubMed 17361338Walter U, Knoblich R, Steinhagen V, Donat M, Benecke R, Kloth A. Predictors of pneumonia in acute stroke patients admitted to a neurological intensive care unit. J Neurol. 2007 Oct;254(10):1323-9. doi: 10.1007/s00415-007-0520-0. Epub 2007 Mar 14.
- Background: PubMed 18048864Vogelgesang A, Grunwald U, Langner S, Jack R, Broker BM, Kessler C, Dressel A. Analysis of lymphocyte subsets in patients with stroke and their influence on infection after stroke. Stroke. 2008 Jan;39(1):237-41. doi: 10.1161/STROKEAHA.107.493635. Epub 2007 Nov 29.
- Background: PubMed 19286597Steinhagen V, Grossmann A, Benecke R, Walter U. Swallowing disturbance pattern relates to brain lesion location in acute stroke patients. Stroke. 2009 May;40(5):1903-6. doi: 10.1161/STROKEAHA.108.535468. Epub 2009 Mar 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uwe Walter, MD study chair
University of Rostock, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke and Pneumonia, run by University of Rostock at 1 site in Germany.
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 3 inclusion and 4 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 19 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
diagnosis of chest infection within 7 days after stroke (time frame: days 1-7 after stroke). 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 NCT00906542, 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 19 Feb 2010.