Austrian Polyintervention Study to Prevent Cognitive Decline After Ischemic Stroke (ASPIS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
NÖ Forschungs- und Bildungsges.m.b.H (NFB)
Information provided by:
Danube University Krems
ClinicalTrials.gov Identifier:
NCT01109836
First received: April 15, 2010
Last updated: December 4, 2012
Last verified: June 2010
  Purpose

Aim of this randomized controlled study is to test if intensive polyintervention therapy including life style modifications targeting at reduction of modifiable risk factors of stroke can reduce the risk of post-stroke cognitive decline compared to a group of patients receiving standard care.


Condition Intervention Phase
Ischemic Stroke
Cognitive Decline
Dementia
Behavioral: Motivation and lifestyle intervention
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: ASPIS-Austrian Polyintervention Study to Prevent Cognitive Decline After Ischemic Stroke

Resource links provided by NLM:


Further study details as provided by Danube University Krems:

Primary Outcome Measures:
  • Number of persons having cognitively declined at 24 months [ Time Frame: 24 months after randomization ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    Difference between the measures at baseline and at 24 months on the Cognitive Subscale of the Alzheimer's disease assessment scale (ADAS-cog).


Secondary Outcome Measures:
  • Number of persons having cognitively declined 12 months after randomization [ Time Frame: 12 months after randomization ] [ Designated as safety issue: No ]
    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.

  • Cognitive decline on the Cognitive Subscale of the Alzheimer's disease assessment scale (ADAS-cog) at 12 months [ Time Frame: 12 months after randomization ] [ Designated as safety issue: No ]
    Difference between the measures at baseline and at 12 months on the Cognitive Subscale of the Alzheimer's disease assessment scale (ADAS-cog).

  • Cognitive impairment on the Mini-Mental-State-Examination (MMSE) scale at 12 months [ Time Frame: 12 months after randomization ] [ Designated as safety issue: No ]
  • Cognitive impairment on the Mini-Mental-State-Examination (MMSE) scale at 24 months [ Time Frame: 24 months after randomization ] [ Designated as safety issue: No ]
  • Change in cognitive abilities measured by composite scores for each of 5 cognitive domains [ Time Frame: 12 months after randomization ] [ Designated as safety issue: No ]
    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.

  • Composite outcome for vascular events [ Time Frame: 24 months after randomization ] [ Designated as safety issue: Yes ]
    vascular events include recurrent stroke, ACS, bypass surgery, PTA and vascular death

  • Neurological status on the National Institute of Health Stroke Scale (NIHSS) score [ Time Frame: 12 months after randomization ] [ Designated as safety issue: No ]
  • Functional status on the modified Rankin Scale [ Time Frame: 12 months after randomization ] [ Designated as safety issue: No ]
  • Activities of daily living on Barthel Index [ Time Frame: 12 months after randomization ] [ Designated as safety issue: No ]
  • Quality of life on the EQ-5D [ Time Frame: 12 months after randomization ] [ Designated as safety issue: No ]
  • Depression on the Center for Epidemiologic Studies Depression Scale (CESD) [ Time Frame: 12 months after randomization ] [ Designated as safety issue: No ]
  • All cause mortality [ Time Frame: 24 months after randomization ] [ Designated as safety issue: Yes ]
  • Change in cognitive abilities measured by composite scores for each of 5 cognitive domains [ Time Frame: 24 months after randomization ] [ Designated as safety issue: No ]
    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.

  • Neurological status on the National Institute of Health Stroke Scale (NIHSS)score [ Time Frame: 24 months after randomization ] [ Designated as safety issue: No ]
  • Functional status on the modified Rankin Scale [ Time Frame: 24 months after randomization ] [ Designated as safety issue: No ]
  • Activities of daily living on Barthel Index [ Time Frame: 24 months after randomization ] [ Designated as safety issue: No ]
  • Quality of life on the EQ-5D [ Time Frame: 24 months after randomization ] [ Designated as safety issue: No ]
  • Depression on the Center for Epidemiologic Studies Depression Scale (CESD) [ Time Frame: 24 months after randomization ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: June 2010
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Motivation and lifestyle intervention
Intensive control and motivation for better compliance with medication, regular blood pressure measurements, diet changes and physical activity.
Behavioral: Motivation and lifestyle intervention
Intensive control and motivation for better compliance with medication, regular blood pressure measurements, diet changes and physical activity.
No Intervention: Control
Standard stroke care

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01109836

Locations
Austria
Dept of Neurology Landesklinikum Waldviertel Horn / Allentsteig
Horn, Austria, 3580
Dept of Neurology, Landesklinikum Mostviertel Amstetten-Mauer
Mauer bei Amstetten, Austria, 3362
Dept. Neurology, LK St.Pölten
St. Pölten, Austria, 3100
Dept of Neurology, Landesklinikum Donauregion Tulln
Tulln, Austria, A-3430
Dept of Neurology, Landesklinikum Wr. Neustadt
Wr. Neustadt, Austria, A-2700
Sponsors and Collaborators
Danube University Krems
NÖ Forschungs- und Bildungsges.m.b.H (NFB)
Investigators
Principal Investigator: Michael Brainin, Prof. MD Danube University Krems
  More Information

No publications provided

Responsible Party: Prim. Univ. Prof. Dr. Michael Brainin, Danube University Krems
ClinicalTrials.gov Identifier: NCT01109836     History of Changes
Other Study ID Numbers: DUK-2010-001, LS 09-002
Study First Received: April 15, 2010
Last Updated: December 4, 2012
Health Authority: Austria: Federal Ministry for Health

Keywords provided by Danube University Krems:
prevention
cognitive decline
post-stroke dementia
life-style intervention
vascular risk factors
polyintervention
multifactorial treatment

Additional relevant MeSH terms:
Dementia
Ischemia
Stroke
Cerebral Infarction
Cognition Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Pathologic Processes
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 20, 2014