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Improved Stroke Outcome at 6 Months
This study has been completed.
Sponsors and Collaborators: Kantonsspital Baden
RehaClinic Zurzach
Information provided by: Kantonsspital Baden
ClinicalTrials.gov Identifier: NCT00122798
  Purpose

The investigators implemented a structured chain of acute stroke care with early integrated rehabilitation. The mortality at 6 months was lower (12%) compared to 23% in the International Stroke Trial (IST) and 39% (67%) of the patients were dead or dependent, which is superior compared to international data.


Condition Intervention Phase
Stroke
Procedure: Stroke treatment
Phase IV

Genetics Home Reference related topics: familial atrial fibrillation
MedlinePlus related topics: Rehabilitation
U.S. FDA Resources
Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study
Official Title: Improved Stroke Outcome at 6 Months Attained by a Chain of Structured Acute Treatment With Integrated Rehabilitation and Supported Discharge

Further study details as provided by Kantonsspital Baden:

Estimated Enrollment: 200
Study Start Date: January 2002
Estimated Study Completion Date: January 2005
Detailed Description:

Background/Aim of the study: To further reduce the 6 months stroke morbidity and mortality in a high volume stroke hospital and to compare the results with national and international data.

Methods: 204 consecutive stroke patients are analyzed in a prospective study in a single center teaching institution. The intervention consists of a structured therapeutic chain of 290 collaborating GPs, a standardised acute hospital proceeding overlapping with an early integrated neurovascular rehabilitation within the same institution. Primary endpoints include death and dependence at 6 months, secondary endpoints are the length of hospital stay (LOS) and the quantitative analysis of physical and psychosocial impairments. The data are directly compared with the same endpoints of the Swiss subgroup of the international stroke trial (IST) and recent international data.

Results: At 6 months, mortality is significantly lower with 12 % (compared to 23 % in the IST trial) and only 39 % (67 %) of the patients are dead or dependent. Stroke severity is similar as in other study populations. Median LOS is 15 days in the acute clinic and 39 days in the rehabilitation institution. The psychosocial outcome compares favorably to a matched control group.

Conclusions: A structured chain of acute stroke treatment overlapping with an early integrated rehabilitation is superior compared to national and international ischemic stroke trial data.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • An acute cerebrovascular event (ischemic stroke or intra-cerebral bleeding (ICB)) with the signs and symptoms of an acute stroke according to the World Health Organisation definition of acute stroke within the last 12 hours without the need or possibility of a neurosurgical intervention;
  • No thrombolytic therapy within the first 3 hours (in order to allow the correct comparison with the Swiss cohort of the IST trial)
  • The informed consent of the patient or, if not possible, of the next of kindred
  • Living at home before the event
  • Lack of participation in another trial

Exclusion Criteria:

  • Transient ischemic attack (TIA) resp. full recovery within 24 hours after the event
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00122798

Locations
Switzerland, Aargau
Kantonsspital Baden
Baden, Aargau, Switzerland, 5404
Sponsors and Collaborators
Kantonsspital Baden
RehaClinic Zurzach
Investigators
Principal Investigator: Juerg H Beer, M.D Dept of Medicine, Kantonsspital Baden, Switzerland
  More Information

Related Info  This link exits the ClinicalTrials.gov site

Study ID Numbers: EK 50
Study First Received: July 21, 2005
Last Updated: June 23, 2006
ClinicalTrials.gov Identifier: NCT00122798  
Health Authority: Switzerland: Swissmedic

Keywords provided by Kantonsspital Baden:
Stroke, stroke treatment, atrial fibrillation, medication, rehabilitation

Study placed in the following topic categories:
Cerebral Infarction
Stroke
Vascular Diseases
Brain Ischemia
Central Nervous System Diseases
Ischemia
Brain Infarction
Atrial Fibrillation
Brain Diseases
Infarction
Cerebrovascular Disorders

Additional relevant MeSH terms:
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009