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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01107548
Other study ID # 080250hb
Secondary ID
Status Terminated
Phase N/A
First received April 19, 2010
Last updated February 16, 2012
Start date January 2001
Est. completion date March 2010

Study information

Verified date April 2010
Source Technische Universität München
Contact n/a
Is FDA regulated No
Health authority Germany: The Bavarian State Ministry of the Environment and Public Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 3908
Est. completion date March 2010
Est. primary completion date December 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 55 Years and older
Eligibility Inclusion Criteria:

- Age 55 years or over

- Member of a particular health insurance plan (AOK)

- Resident of the district of Ebersberg

Exclusion Criteria:

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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


Locations

Country Name City State
Germany Depts. of Psychiatry and Neurology, Technische Universität München Munich

Sponsors (9)

Lead Sponsor Collaborator
Technische Universität München Allgemeine Ortskrankenkasse Bayern (AOK), Bayer, Berlin-Chemie Menarini, Organon, Ratiopharm GmbH, Sanofi-Synthelabo, Stiftung Deutsche Schlaganfall-Hilfe, Teva Pharma GmbH

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. Epub 2005 Dec 22. — View Citation

Sander K, Bickel H, Schulze Horn C, Huntgeburth U, Poppert H, Sander D. [Peripheral arterial disease: predictors and treatment intensity. Two-years of data from the population-based INVADE project]. Dtsch Med Wochenschr. 2008 Mar;133(10):455-9. doi: 10.10 — View Citation

Scherpinski U, Bickel H, Gnahn H, Förstl 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. German. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of long-term care disability 8 years No
Primary Incidence of stroke 8 Years No
Secondary Reduction of cardiovascular risk factors 8 years No
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