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| Sponsor: | Sykehuset Asker og Baerum |
|---|---|
| Collaborator: |
University of Oslo |
| Information provided by: | Sykehuset Asker og Baerum |
| ClinicalTrials.gov Identifier: | NCT00506818 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Stroke Cognitive Impairment Vascular Dementia |
Other: Multifactorial vascular-risk-factor-intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Prevention |
| Official Title: | Cognitive and Emotional Impairment After Stroke |
| Estimated Enrollment: | 250 |
| Study Start Date: | February 2007 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 2
Intensive risk factor intervention
|
Other: Multifactorial vascular-risk-factor-intervention |
Eligibility| Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Norway | |
| Sykehuset Asker og Baerum HF | |
| Pb 83, 1309, Norway, RUD | |
| Principal Investigator: | Hege Ihle-Hansen, MD | Sykehuset Asker og Baerum |
More Information
| ClinicalTrials.gov Identifier: | NCT00506818 History of Changes |
| Other Study ID Numbers: | 1.2006.2076(REK), 1.2006.2076(REK), 16307(NSD) |
| Study First Received: | July 23, 2007 |
| Last Updated: | September 18, 2009 |
| Health Authority: | Norway: The National Committees for Research Ethics in Norway; Norway: Norwegian Social Science Data Services |
|
emotional symptoms vascular risk-factors |
|
Dementia Dementia, Vascular Stroke Cerebral Infarction Cognition Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
Cerebrovascular Disorders Intracranial Arteriosclerosis Intracranial Arterial Diseases Leukoencephalopathies Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |