Prevention of Stroke and Dementia in Primary Care | NCT01107548

Studies
Prevention of Stroke and Dementia in Primary Care

NCT01107548

Sponsor

Technical University of Munich

Status

Terminated

Last Update Posted

Feb 20, 2012Estimated

Enrollment

3,908Actual

Phase

Not Applicable

Conditions

Stroke
Dementia
Disability

Interventions

Systematic detection of vascular risk factors and subsequent evidence-based treatment

Countries

Germany

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

Apr 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2001

Primary Completion Date

Dec 2008Actual

Completion Date

Mar 2010Actual

First Submitted Date

Apr 19, 2010

First Submission Date that Met QC Criteria

Apr 19, 2010

First Posted Date

Apr 21, 2010Estimated

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

Feb 16, 2012

Last Update Posted Date

Feb 20, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Technical University of MunichOTHER

Collaborators

Name	Class
AOK Bayern	INDUSTRY
Stiftung Deutsche Schlaganfall-Hilfe	UNKNOWN
Ratiopharm GmbH	INDUSTRY
Sanofi-Synthelabo

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

In Western Countries, stroke and dementia are the main causes of long-term disability, dependency, and nursing home admission. Due to demographic trends a continuous increase of patient numbers can be expected.

There is growing evidence that vascular risk factors which are implicated in the etiology of stroke also play important etiologic roles in both vascular dementia and Alzheimer disease. The present project is aimed at the reduction of stroke and dementia by means of a systematic detection and subsequent treatment of vascular risk factors by the family doctor based on established guidelines.

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

3,908Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Evidence-based treatment, lifestyle counseling	Experimental		Other: Systematic detection of vascular risk factors and subsequent evidence-based treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Systematic detection of vascular risk factors and subsequent evidence-based treatment	Other		Evidence-based treatment, lifestyle counseling

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of long-term care disability		8 years
Incidence of stroke		8 Years

Secondary Outcomes

Measure	Description	Time Frame
Reduction of cardiovascular risk factors		8 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 55 years or over
Member of a particular health insurance plan (AOK)
Resident of the district of Ebersberg

Exclusion Criteria:

None

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Horst Bickel, PhD	Dept. of Psychiatry, Technical University of Munich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Depts. of Psychiatry and Neurology, Technische Universität München		Munich		D-81675	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12486573	Result	Scherpinski U, Bickel H, Gnahn H, Forstl H, Conrad B, Sander D. [Intervention project on cerebrovascular diseases and dementia in the Ebersberg district (INVADE): rationale and design]. Nervenarzt. 2002 Dec;73(12):1199-204. doi: 10.1007/s00115-002-1443-8. German.
16373634	Result	Sander D, Schulze-Horn C, Bickel H, Gnahn H, Bartels E, Conrad B. Combined effects of hemoglobin A1c and C-reactive protein on the progression of subclinical carotid atherosclerosis: the INVADE study. Stroke. 2006 Feb;37(2):351-7. doi: 10.1161/01.STR.0000199034.26345.bc. Epub 2005 Dec 22.

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