Cognitive and Emotional Impairment After Stroke | NCT00506818

Studies
Cognitive and Emotional Impairment After Stroke

NCT00506818

Sponsor

Sykehuset Asker og Baerum

Status

Completed

Last Update Posted

Sep 21, 2009Estimated

Enrollment

250Estimated

Phase

Not Applicable

Conditions

Stroke
Cognitive Impairment
Vascular Dementia

Interventions

Multifactorial vascular-risk-factor-intervention

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2007

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Jul 23, 2007

First Submission Date that Met QC Criteria

Jul 23, 2007

First Posted Date

Jul 25, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2009

Last Update Posted Date

Sep 21, 2009Estimated

Name	Class
University of Oslo	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2	Active Comparator	Intensive risk factor intervention	Other: Multifactorial vascular-risk-factor-intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Multifactorial vascular-risk-factor-intervention	Other		2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effects of vascular risk-factor-intervention on changes in TMTA, ten-words-test and HAD		8-12 months after stroke onset

Secondary Outcomes

Measure	Description	Time Frame
Prevalence of dementia and depression after stroke		8-12 month after stroke onset

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Cognitive decline

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hege Ihle-Hansen, MD	Sykehuset Asker og Baerum	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sykehuset Asker og Baerum HF		Pb 83	1309	RUD	Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32384876	Derived	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.
28583116	Derived

ID	Term
D020521	Stroke
D060825	Cognitive Dysfunction
D015140	Dementia, Vascular

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Type	Description	Link
1.2006.2076(REK)
16307(NSD)