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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 23, 2007 | ||||
| Last Updated Date | September 18, 2009 | ||||
| Start Date ICMJE | February 2007 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Effects of vascular risk-factor-intervention on changes in TMTA, ten-words-test and HAD [ Time Frame: 8-12 months after stroke onset ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00506818 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Prevalence of dementia and depression after stroke [ Time Frame: 8-12 month after stroke onset ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Cognitive and Emotional Impairment After Stroke | ||||
| Official Title ICMJE | Cognitive and Emotional Impairment After Stroke | ||||
| Brief Summary | Cognitive and emotional symptoms are often seen in the acute phase of a stroke. The prevalence of such symptoms later and the mechanisms explaining the symptoms are not fully known. The causes of poststroke dementia are likely to be multifactorial (Cerebrovascular Diseases 2006). The investigators want to include all patients with first ever stroke without significant cognitive decline prior to the stroke (IQCODE cut-off 3,7) and follow them up for one year. At baseline we will make stroke classifications, measure neurological deficits according to NIHSS, evaluate cognitive and emotional function and make registrations of vascular risk factors, including precerebral color duplex scan with measurement of IMT in CCA. The investigators will then randomize the patients into multifactorial vascular-risk-factor-intervention in the hospital or care as usual in the primary health care. 8-12 months after stroke onset, survivors will undergo new examinations to evaluate neurological, cognitive and emotional functions, as well as MRI and SPECT. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Single Blind, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Other: Multifactorial vascular-risk-factor-intervention | ||||
| Study Arms / Comparison Groups | Active Comparator: Intensive risk factor intervention | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 250 | ||||
| Completion Date | June 2009 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | |||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Norway | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00506818 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 1.2006.2076(REK), 1.2006.2076(REK), 16307(NSD) | ||||
| Study Sponsor ICMJE | Sykehuset Asker og Baerum | ||||
| Collaborators ICMJE | University of Oslo | ||||
| Investigators ICMJE |
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| Information Provided By | Sykehuset Asker og Baerum | ||||
| Verification Date | September 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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