NCT00506818

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Feb 2007

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

September 21, 2009

Status Verified

September 1, 2009

Enrollment Period

2.3 years

First QC Date

July 23, 2007

Last Update Submit

September 18, 2009

Conditions

StrokeCognitive ImpairmentVascular Dementia

Keywords

emotional symptomsvascular risk-factors

Outcome Measures

Primary Outcomes (1)

  • Effects of vascular risk-factor-intervention on changes in TMTA, ten-words-test and HAD

    8-12 months after stroke onset

Secondary Outcomes (1)

  • Prevalence of dementia and depression after stroke

    8-12 month after stroke onset

Study Arms (1)

2

ACTIVE COMPARATOR

Intensive risk factor intervention

Other: Multifactorial vascular-risk-factor-intervention

Interventions

Multifactorial vascular-risk-factor-interventionOTHER
2

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • First ever stroke or TIA
  • No cognitive decline (IQCODE \< 3,7)
  • Survived the acute stroke
  • Expected to live at least for one year after stroke

You may not qualify if:

  • Cognitive decline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sykehuset Asker og Baerum HF

Pb 83, 1309, RUD, Norway

Location

Related Publications (4)

  • Hagberg G, Ihle-Hansen H, Fure B, Thommessen B, Ihle-Hansen H, Oksengard AR, Beyer MK, Wyller TB, Muller EG, Pendlebury ST, Selnes P. No evidence for amyloid pathology as a key mediator of neurodegeneration post-stroke - a seven-year follow-up study. BMC Neurol. 2020 May 8;20(1):174. doi: 10.1186/s12883-020-01753-w.

    PMID: 32384876DERIVED

  • Ihle-Hansen H, Hagberg G, Fure B, Thommessen B, Fagerland MW, Oksengard AR, Engedal K, Selnes P. Association between total-Tau and brain atrophy one year after first-ever stroke. BMC Neurol. 2017 Jun 5;17(1):107. doi: 10.1186/s12883-017-0890-6.

    PMID: 28583116DERIVED

  • Ihle-Hansen H, Thommessen B, Fagerland MW, Oksengard AR, Wyller TB, Engedal K, Fure B. Blood pressure control to prevent decline in cognition after stroke. Vasc Health Risk Manag. 2015 Jun 9;11:311-6. doi: 10.2147/VHRM.S82839. eCollection 2015.

    PMID: 26089677DERIVED

  • Ihle-Hansen H, Thommessen B, Fagerland MW, Oksengard AR, Wyller TB, Engedal K, Fure B. Effect on anxiety and depression of a multifactorial risk factor intervention program after stroke and TIA: a randomized controlled trial. Aging Ment Health. 2014 Jul;18(5):540-6. doi: 10.1080/13607863.2013.824406. Epub 2013 Aug 20.

    PMID: 23957255DERIVED

MeSH Terms

Conditions

StrokeCognitive DysfunctionDementia, Vascular

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesCognition DisordersNeurocognitive DisordersMental DisordersIntracranial ArteriosclerosisIntracranial Arterial DiseasesDementiaLeukoencephalopathiesArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Hege Ihle-Hansen, MD

    Sykehuset Asker og Baerum

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 23, 2007

First Posted

July 25, 2007

Study Start

February 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

September 21, 2009

Record last verified: 2009-09

Locations

NO(1)