StrokeNCT00122798
Improved Stroke Outcome at 6 Months
An observational study of Stroke, run by Kantonsspital Baden at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Stroke treatment
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2002to Jan 2005
- 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
Who may be able to join
- 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
Who cannot join
- Transient ischemic attack (TIA) resp. full recovery within 24 hours after the event
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improved Stroke Outcome at 6 Months Attained by a Chain of Structured Acute Treatment With Integrated Rehabilitation and Supported Discharge
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Stroke treatment
- Keywords
- Stroke, stroke treatment, atrial fibrillation, medication, rehabilitation
- Medical subject headings
- Stroke, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stroke treatmentProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startJan 2002
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Defined population
- Time perspective
- Prospective
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Kantonsspital Baden
- Sponsor type
- University, hospital or other
- Collaborators
- RehaClinic Zurzach
- Investigators
- Juerg H Beer, M.D, Principal investigator, Dept of Medicine, Kantonsspital Baden, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00122798
- Sponsor's protocol ID
- EK 50
- Status last verified
- Dec 2004
- First submitted
- 21 Jul 2005
- Last updated
- 27 Jun 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Stroke Outcome at 6 Months Attained by a Chain of Structured Acute Treatment With Integrated Rehabilitation and Supported Discharge
- ClinicalTrials.gov ID
- NCT00122798
- Acronym / sponsor ID
- EK 50
- Conditions
- Stroke
- Keywords
- Stroke, stroke treatment, atrial fibrillation, medication, rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Kantonsspital BadenUniversity, hospital or other
- Collaborators
- RehaClinic Zurzach
- Study start
- Jan 2002
- Study completion
- Jan 2005
- First posted
- 22 Jul 2005 (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.
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.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Transient ischemic attack (TIA) resp. full recovery within 24 hours after the event
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stroke treatment | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 27 Jun 2006.
- Related InfoLink provided by the sponsor.
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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.
Juerg H Beer, M.D principal investigator
Dept of Medicine, Kantonsspital Baden, Switzerland
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 Stroke, run by Kantonsspital Baden at 1 site in Switzerland.
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 5 inclusion and 1 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 27 Jun 2006. 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 Switzerland. 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.
Where can I read the original study information?
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 27 Jun 2006.