Predictors of Early Chest Infection in Acute Ischemic Stroke (PRECAST)

This study has been completed.
Sponsor:
Information provided by:
University of Rostock
ClinicalTrials.gov Identifier:
NCT00906542
First received: May 20, 2009
Last updated: February 18, 2010
Last verified: February 2010
  Purpose

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.


Condition
Acute Ischemic Stroke
Pneumonia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictors of Early Chest Infection in Acute Ischemic Stroke

Resource links provided by NLM:


Further study details as provided by University of Rostock:

Primary Outcome Measures:
  • diagnosis of chest infection within 7 days after stroke [ Time Frame: days 1-7 after stroke ] [ Designated as safety issue: No ]

Enrollment: 530
Study Start Date: May 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Acute ischemic stroke patients admitted to the neurological intensive care unit or stroke unit within 24 hours after stroke onset

Criteria

Inclusion Criteria:

  • acute ischemic stroke
  • admission to the neurological intensive care unit or stroke unit within 24 hours after stroke onset
  • clearly assessed brain lesion location

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00906542

Locations
Germany
University of Rostock, Department of Neurology
Rostock, Germany, D-18147
Sponsors and Collaborators
University of Rostock
Investigators
Study Chair: Uwe Walter, MD University of Rostock, Germany
  More Information

Publications:
Responsible Party: Prof. Dr. Uwe Walter, University of Rostock, Department of Neurology
ClinicalTrials.gov Identifier: NCT00906542     History of Changes
Other Study ID Numbers: PRECAST-01
Study First Received: May 20, 2009
Last Updated: February 18, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by University of Rostock:
acute stroke
ischemic stroke
pneumonia
chest infection
brain lesion
lesion topology
dysphagia
sympathetic activation
immunosuppression

Additional relevant MeSH terms:
Ischemia
Pneumonia
Stroke
Cerebral Infarction
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 18, 2014