Acute Ischemic StrokeQuAStNCT00574262
Quality Assessment in Acute Stroke Care
An observational study of Acute Ischemic Stroke, run by University Hospital Muenster at 1 site in Germany.
Trial summary
The purpose of the study is to evaluate the quality of care on a 16 bed stroke unit by using a new developed clinical pathway. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Ischemic Stroke
- How many people
- 400 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2007to Apr 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with an acute ischemic stroke admitted to the stroke unit of the university hospital in Muenster, Germany
Who may be able to join
- admission to the stroke unit of the university hospital in Muenster, Germany
- acute ischemic stroke or transient ischemic attack
Who cannot join
- intracerebral haemorrhage
- neurological symptoms due to other pathology than acute ischemic stroke or transient ischemic attack
- intraarterial thrombolysis
- necessity of artificial ventilation
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Neurology, University Hospital of Muenster
Münster, 48149
Christoffer Kraemer, MD, 0049-251-8348016, kraemec@uni-muenster.de
Christoffer Kraemer, MD
About this study
Official title: Quality of Acute Stroke Care Evaluated With a Clinical Pathway on a 16 Bed Stroke Unit - a Prospective Trial
The purpose of the study is to evaluate the quality of care on a 16 bed stroke unit by using a new developed clinical pathway.
- Conditions
- Acute Ischemic Stroke
- Keywords
- acute ischemic stroke, clinical pathway, quality of care, secondary prevention
- Medical subject headings
- Ischemic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency of patients monitored according to the specific german procedure standard (OPS-code 8-981) (preset target 90 - 95 %)
Measured: duration of stay on stroke unit
Secondary outcomes (6)
frequency of stroke been classified according to the TOAST criteria (preset target 55 - 65 %)
Measured: duration of stay on stroke unit
frequency of initiated or improved antithrombotic secondary prevention (preset target 90 - 95 %)
Measured: duration of stay on stroke unit
frequency of initiated or improved statin therapy (preset target 40 - 50 %)
Measured: duration of stay on stroke unit
frequency of totally completed clinical diagnostics regarding the etiology of the stroke (preset target 60 -70 %)
Measured: duration of stay on stroke unit
frequency of initiated or improved antihypertension therapy and reduction of systolic and diastolic blood pressure by more than 10 mmHg (preset target 60 - 70 %)
Measured: duration of stay on stroke unit
frequency of a reduction on the NIH-SS by at least two points (preset target 50 - 60 %)
Measured: duration of stay on stroke unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2007 (estimated)
- Study startOct 2007
- Study completionApr 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Investigators
- Wolf Rüdiger Schäbitz, MD, Principal investigator, Department of Neurology, University Hospital of Muenster, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00574262
- Sponsor's protocol ID
- ClinPathStroke
- Acronym
- QuASt
- Status last verified
- Nov 2007
- First submitted
- 23 Nov 2007
- Last updated
- 13 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Heuschmann PU, Biegler MK, Busse O, Elsner S, Grau A, Hasenbein U, Hermanek P, Janzen RW, Kolominsky-Rabas PL, Kraywinkel K, Lowitzsch K, Misselwitz B, Nabavi DG, Otten K, Pientka L, von Reutern GM, Ringelstein EB, Sander D, Wagner M, Berger K. Development and implementation of evidence-based indicators for measuring quality of acute stroke care: the Quality Indicator Board of the German Stroke Registers Study Group (ADSR). Stroke. 2006 Oct;37(10):2573-8. doi: 10.1161/01.STR.0000241086.92084.c0. Epub 2006 Sep 7.
PubMed 16960092Kwan J. Care pathways for acute stroke care and stroke rehabilitation: from theory to evidence. J Clin Neurosci. 2007 Mar;14(3):189-200. doi: 10.1016/j.jocn.2006.01.026.
PubMed 17258128Taylor WJ, Wong A, Siegert RJ, McNaughton HK. Effectiveness of a clinical pathway for acute stroke care in a district general hospital: an audit. BMC Health Serv Res. 2006 Feb 23;6:16. doi: 10.1186/1472-6963-6-16.
PubMed 16504101
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Acute Stroke Care Evaluated With a Clinical Pathway on a 16 Bed Stroke Unit - a Prospective Trial
- ClinicalTrials.gov ID
- NCT00574262
- Acronym / sponsor ID
- QuASt / ClinPathStroke
- Conditions
- Acute Ischemic Stroke
- Keywords
- acute ischemic stroke, clinical pathway, quality of care, secondary prevention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- Oct 2007
- Study completion
- Apr 2009 (estimated)
- First posted
- 17 Dec 2007 (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 purpose of the study is to evaluate the quality of care on a 16 bed stroke unit by using a new developed clinical pathway.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with an acute ischemic stroke admitted to the stroke unit of the university hospital in Muenster, Germany
Key inclusion criteria (2 listed)
- admission to the stroke unit of the university hospital in Muenster, Germany
- acute ischemic stroke or transient ischemic attack
Key exclusion criteria (4 listed)
- intracerebral haemorrhage
- neurological symptoms due to other pathology than acute ischemic stroke or transient ischemic attack
- intraarterial thrombolysis
- necessity of artificial ventilation
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
frequency of patients monitored according to the specific german procedure standard (OPS-code 8-981) (preset target 90 - 95 %)
Time frame: duration of stay on stroke unit
6 secondary outcomes
frequency of stroke been classified according to the TOAST criteria (preset target 55 - 65 %)
Time frame: duration of stay on stroke unit
frequency of initiated or improved antithrombotic secondary prevention (preset target 90 - 95 %)
Time frame: duration of stay on stroke unit
frequency of initiated or improved statin therapy (preset target 40 - 50 %)
Time frame: duration of stay on stroke unit
frequency of totally completed clinical diagnostics regarding the etiology of the stroke (preset target 60 -70 %)
Time frame: duration of stay on stroke unit
frequency of initiated or improved antihypertension therapy and reduction of systolic and diastolic blood pressure by more than 10 mmHg (preset target 60 - 70 %)
Time frame: duration of stay on stroke unit
frequency of a reduction on the NIH-SS by at least two points (preset target 50 - 60 %)
Time frame: duration of stay on stroke unit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2010.
- Background: PubMed 16960092Heuschmann PU, Biegler MK, Busse O, Elsner S, Grau A, Hasenbein U, Hermanek P, Janzen RW, Kolominsky-Rabas PL, Kraywinkel K, Lowitzsch K, Misselwitz B, Nabavi DG, Otten K, Pientka L, von Reutern GM, Ringelstein EB, Sander D, Wagner M, Berger K. Development and implementation of evidence-based indicators for measuring quality of acute stroke care: the Quality Indicator Board of the German Stroke Registers Study Group (ADSR). Stroke. 2006 Oct;37(10):2573-8. doi: 10.1161/01.STR.0000241086.92084.c0. Epub 2006 Sep 7.
- Background: PubMed 17258128Kwan J. Care pathways for acute stroke care and stroke rehabilitation: from theory to evidence. J Clin Neurosci. 2007 Mar;14(3):189-200. doi: 10.1016/j.jocn.2006.01.026.
- Background: PubMed 16504101Taylor WJ, Wong A, Siegert RJ, McNaughton HK. Effectiveness of a clinical pathway for acute stroke care in a district general hospital: an audit. BMC Health Serv Res. 2006 Feb 23;6:16. doi: 10.1186/1472-6963-6-16.
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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.
Wolf Rüdiger Schäbitz, MD principal investigator
Department of Neurology, University Hospital of Muenster, 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, run by University Hospital Muenster 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 2 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: status not confirmed, as of the sponsor's last update on 13 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wolf Rüdiger Schäbitz, MD (0049-251-8345235, schabitz@uni-muenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
frequency of patients monitored according to the specific german procedure standard (OPS-code 8-981) (preset target 90 - 95 %) (time frame: duration of stay on stroke unit). 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 NCT00574262, which also lists 3 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 13 Jan 2010; AzTrials last refreshed its copy on 31 Oct 2026.