- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01109836
Austrian Polyintervention Study to Prevent Cognitive Decline After Ischemic Stroke (ASPIS)
ASPIS-Austrian Polyintervention Study to Prevent Cognitive Decline After Ischemic Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Stroke is the second most frequent cause of death and cognitive deficits including dementia occur frequently following a stroke. The frequency of cognitive disturbances has been reported up to 30% and thus occurs three times more frequent than recurrent stroke (10%). Major attempts have been made to prevent the occurrence of new strokes by means of effective strategies including preventive drugs. In contrast, hardly any studies have been performed addressing the prevention of deteriorating cognitive function following a stroke. In spite of this high prevalence therapeutic possibilities are extremely limited. It must be expected that cognitive deficits become even a more frequent disability following stroke. This is caused by the increased aging of the population leading to further increase of incidence, furthermore that more people survive their acute stroke due to increased possibilities of acute treatment, and that frequent risk factors (e.g. hypertension, diabetes) are increasingly controlled, thus leading to less severe strokes with less severe and permanent motor deficits, but an increase of potentially disabling cognitive disturbances. The aim of this randomized controlled study is to test an intensive multiple intervention therapy for the first time in stroke and to add life style modifications targeting modifiable risk factors for cognitive deterioration.
It is hypothesized that the risk of post-stroke cognitive decline can be significantly reduced compared to a control group with standard care when using polyintervention. These interventions will focus on nutrition, exercise, cognitive and social activity and monitoring and management of metabolic and vascular risk factors. Regular contacts with the subjects shall increase motivation and adherence to the study protocol.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Horn, Austria, 3580
- Dept of Neurology Landesklinikum Waldviertel Horn / Allentsteig
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Mauer bei Amstetten, Austria, 3362
- Dept of Neurology, Landesklinikum Mostviertel Amstetten-Mauer
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St. Pölten, Austria, 3100
- Dept. Neurology, LK St.Pölten
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Tulln, Austria, A-3430
- Dept of Neurology, Landesklinikum Donauregion Tulln
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Wr. Neustadt, Austria, A-2700
- Dept of Neurology, Landesklinikum Wr. Neustadt
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Symptomatic ischemic stroke with clinical syndrome of stroke and a corresponding ischemic lesion.
- MRI or CT results compatible with clinical diagnosis of acute ischemic stroke
- NIH Stroke Scale Score on admission 1 to 14, both inclusive
- Modified Rankin Scale before stroke 0 to 2, inclusive
- Randomization within 3 months after stroke onset (goal: 80% within 3 weeks)
- Sufficient communication possible
- Informed consent given by the patient and/or the patient's legally acceptable representative
Exclusion Criteria:
- Substantial cognitive decline (Mini Mental State Examination (MMSE) score > 24) or pre-existing dementia or Parkinson disease
- Persistent disturbed level of consciousness
- Persistent aphasia
- Pre-existing significant psychiatric diseases (i.e. Schizophrenia, Major Depression, Bipolar Disorders, all according to DSMIV); Patients with minor Depression (DSM IV) can be included
- Severe sensory impairment making neuropsychological testing impossible
- Severe comorbidity (e.g. unstable or severe cardiovascular or pulmonal disease, neoplasm, severe liver or renal insufficiency and symptomatic stenosis of the ipsilateral carotid artery, cancer…)
- Unreliability for follow up
- Unwillingness or inability to participate or to sign the informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Motivation and lifestyle intervention
Intensive control and motivation for better compliance with medication, regular blood pressure measurements, diet changes and physical activity.
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Intensive control and motivation for better compliance with medication, regular blood pressure measurements, diet changes and physical activity.
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No Intervention: Control
Standard stroke care
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of persons having cognitively declined at 24 months
Time Frame: 24 months after randomization
|
Cognitive decline is defined as a significant decline in the composite scores of at least 2 of 5 neuropsychologically tested domains (speed of mental processing, executive functions, working memory, memory, spatial constructive functions).
The alpha level for the decision is 0.05.
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24 months after randomization
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Cognitive decline measured on the Cognitive Subscale of the Alzheimer's disease assessment scale (ADAS-cog) at 24 months
Time Frame: 24 months after randomization
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Difference between the measures at baseline and at 24 months on the Cognitive Subscale of the Alzheimer's disease assessment scale (ADAS-cog).
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24 months after randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of persons having cognitively declined 12 months after randomization
Time Frame: 12 months after randomization
|
Cognitive decline is defined as a significant decline in the composite scores of at least 2 of 5 neuropsychologically tested domains (speed of mental processing, executive functions, working memory, memory, spatial constructive functions).
The alpha level for the decision is 0.05.
|
12 months after randomization
|
Cognitive decline on the Cognitive Subscale of the Alzheimer's disease assessment scale (ADAS-cog) at 12 months
Time Frame: 12 months after randomization
|
Difference between the measures at baseline and at 12 months on the Cognitive Subscale of the Alzheimer's disease assessment scale (ADAS-cog).
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12 months after randomization
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Cognitive impairment on the Mini-Mental-State-Examination (MMSE) scale at 12 months
Time Frame: 12 months after randomization
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12 months after randomization
|
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Cognitive impairment on the Mini-Mental-State-Examination (MMSE) scale at 24 months
Time Frame: 24 months after randomization
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24 months after randomization
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Change in cognitive abilities measured by composite scores for each of 5 cognitive domains
Time Frame: 12 months after randomization
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For each of the five cognitive domains (executive functions, working memory, general memory, speed of cognitive processing, visual spatial ability) standardized composite scores are calculated from the differences between baseline and 12 months in individual neuropsychological test results.
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12 months after randomization
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Composite outcome for vascular events
Time Frame: 24 months after randomization
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vascular events include recurrent stroke, ACS, bypass surgery, PTA and vascular death
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24 months after randomization
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Neurological status on the National Institute of Health Stroke Scale (NIHSS) score
Time Frame: 12 months after randomization
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12 months after randomization
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Functional status on the modified Rankin Scale
Time Frame: 12 months after randomization
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12 months after randomization
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Activities of daily living on Barthel Index
Time Frame: 12 months after randomization
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12 months after randomization
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Quality of life on the EQ-5D
Time Frame: 12 months after randomization
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12 months after randomization
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Depression on the Center for Epidemiologic Studies Depression Scale (CESD)
Time Frame: 12 months after randomization
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12 months after randomization
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All cause mortality
Time Frame: 24 months after randomization
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24 months after randomization
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Change in cognitive abilities measured by composite scores for each of 5 cognitive domains
Time Frame: 24 months after randomization
|
For each of the five cognitive domains (executive functions, working memory, general memory, speed of cognitive processing, visual spatial ability) standardized composite scores are calculated from the differences between baseline and 24 months in individual neuropsychological test results.
|
24 months after randomization
|
Neurological status on the National Institute of Health Stroke Scale (NIHSS)score
Time Frame: 24 months after randomization
|
24 months after randomization
|
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Functional status on the modified Rankin Scale
Time Frame: 24 months after randomization
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24 months after randomization
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Activities of daily living on Barthel Index
Time Frame: 24 months after randomization
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24 months after randomization
|
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Quality of life on the EQ-5D
Time Frame: 24 months after randomization
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24 months after randomization
|
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Depression on the Center for Epidemiologic Studies Depression Scale (CESD)
Time Frame: 24 months after randomization
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24 months after randomization
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael Brainin, Prof. MD, Danube University Krems
Publications and helpful links
General Publications
- Matz K, Tuomilehto J, Teuschl Y, Dachenhausen A, Brainin M. Comparison of oral glucose tolerance test and HbA1c in detection of disorders of glucose metabolism in patients with acute stroke. Cardiovasc Diabetol. 2020 Dec 5;19(1):204. doi: 10.1186/s12933-020-01182-6.
- Matz K, Teuschl Y, Firlinger B, Dachenhausen A, Keindl M, Seyfang L, Tuomilehto J, Brainin M; ASPIS Study Group. Multidomain Lifestyle Interventions for the Prevention of Cognitive Decline After Ischemic Stroke: Randomized Trial. Stroke. 2015 Oct;46(10):2874-80. doi: 10.1161/STROKEAHA.115.009992. Epub 2015 Sep 15.
- Brainin M, Matz K, Nemec M, Teuschl Y, Dachenhausen A, Asenbaum-Nan S, Bancher C, Kepplinger B, Oberndorfer S, Pinter M, Schnider P, Tuomilehto J; ASPIS Study Group. Prevention of poststroke cognitive decline: ASPIS--a multicenter, randomized, observer-blind, parallel group clinical trial to evaluate multiple lifestyle interventions--study design and baseline characteristics. Int J Stroke. 2015 Jun;10(4):627-35. doi: 10.1111/ijs.12188. Epub 2013 Nov 10.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Necrosis
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Brain Ischemia
- Cognition Disorders
- Infarction
- Brain Infarction
- Stroke
- Ischemic Stroke
- Ischemia
- Dementia
- Cognitive Dysfunction
- Cerebral Infarction
Other Study ID Numbers
- DUK-2010-001
- LS 09-002 (Other Grant/Funding Number: Life Science Krems)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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