StrokeINVADENCT01107548
Prevention of Stroke and Dementia in Primary Care
A study testing Systematic detection of vascular risk factors and subsequent evidence-based treatment in people with Stroke and Dementia, run by Technical University of Munich at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Dementia, Disability
- What is being tested?
- Systematic detection of vascular risk factors and subsequent evidence-based treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,908 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2001to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 55 years or over
- Member of a particular health insurance plan (AOK)
- Resident of the district of Ebersberg
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Germany1 site
Depts. of Psychiatry and Neurology, Technische Universität München
Munich, D-81675
About this study
Official title: Intervention Project of Cerebrovascular Diseases and Dementia in the District of Ebersberg
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.
- Conditions
- Stroke, Dementia, Disability
- Being tested
- Systematic detection of vascular risk factors and subsequent evidence-based treatment
- Medical subject headings
- Stroke, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systematic detection of vascular risk factors and subsequent evidence-based treatmentOther
| Study group | Role | What they receive |
|---|---|---|
| Evidence-based treatment, lifestyle counseling | Experimental | Not described Receives: Other: Systematic detection of vascular risk factors and subsequent evidence-based treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of long-term care disability
Measured: 8 years
Incidence of stroke
Measured: 8 Years
Secondary outcomes (1)
Reduction of cardiovascular risk factors
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2010 (estimated)
- Study startJan 2001
- Primary completionDec 2008
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,908 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- AOK Bayern, Stiftung Deutsche Schlaganfall-Hilfe, Ratiopharm GmbH, Sanofi-Synthelabo, Organon, Teva Pharma GmbH, Bayer, Berlin-Chemie Menarini
- Investigators
- Horst Bickel, PhD, Principal investigator, Dept. of Psychiatry, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107548
- Sponsor's protocol ID
- 080250hb
- Acronym
- INVADE
- Status last verified
- Apr 2010
- First submitted
- 19 Apr 2010
- Last updated
- 20 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12486573Sander 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.
PubMed 16373634Sander 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: 10.1055/s-2008-1046731. German.
PubMed 18302095Bickel H, Block M, Gotzler O, Hartmann J, Purner K, Sander D, Forstl H. [Prevention of stroke and dementia in general practice: evaluation of the project INVADE]. Dtsch Med Wochenschr. 2020 Jun;145(12):e61-e70. doi: 10.1055/a-1124-9124. Epub 2020 Apr 16. German.
PubMed 32299118Bickel H, Ander KH, Bronner M, Etgen T, Gnahn H, Gotzler O, Poppert H, Purner K, Sander D, Forstl H. Reduction of Long-Term Care Dependence After an 8-Year Primary Care Prevention Program for Stroke and Dementia: The INVADE Trial. J Am Heart Assoc. 2012 Aug;1(4):e000786. doi: 10.1161/JAHA.112.000786. Epub 2012 Aug 24.
PubMed 23130154
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Project of Cerebrovascular Diseases and Dementia in the District of Ebersberg
- ClinicalTrials.gov ID
- NCT01107548
- Acronym / sponsor ID
- INVADE / 080250hb
- Conditions
- Stroke, Dementia, Disability
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 3,908 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Collaborators
- AOK Bayern, Stiftung Deutsche Schlaganfall-Hilfe, Ratiopharm GmbH, Sanofi-Synthelabo, Organon, Teva Pharma GmbH, Bayer, Berlin-Chemie Menarini
- Study start
- Jan 2001
- Primary completion
- Dec 2008 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 21 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evidence-based treatment, lifestyle counseling | Experimental | Other: Systematic detection of vascular risk factors and subsequent evidence-based treatment |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 55 years or over
- Member of a particular health insurance plan (AOK)
- Resident of the district of Ebersberg
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systematic detection of vascular risk factors and subsequent evidence-based treatment | Other | Evidence-based treatment, lifestyle counseling |
Primary outcome
Incidence of long-term care disability
Time frame: 8 years
Incidence of stroke
Time frame: 8 Years
1 secondary outcome
Reduction of cardiovascular risk factors
Time frame: 8 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2012.
- Results publication: PubMed 12486573Scherpinski 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.
- Results publication: PubMed 16373634Sander 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.
- Results publication: PubMed 18302095Sander 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: 10.1055/s-2008-1046731. German.
- Derived from this study: PubMed 32299118Bickel H, Block M, Gotzler O, Hartmann J, Purner K, Sander D, Forstl H. [Prevention of stroke and dementia in general practice: evaluation of the project INVADE]. Dtsch Med Wochenschr. 2020 Jun;145(12):e61-e70. doi: 10.1055/a-1124-9124. Epub 2020 Apr 16. German.
- Derived from this study: PubMed 23130154Bickel H, Ander KH, Bronner M, Etgen T, Gnahn H, Gotzler O, Poppert H, Purner K, Sander D, Forstl H. Reduction of Long-Term Care Dependence After an 8-Year Primary Care Prevention Program for Stroke and Dementia: The INVADE Trial. J Am Heart Assoc. 2012 Aug;1(4):e000786. doi: 10.1161/JAHA.112.000786. Epub 2012 Aug 24.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Horst Bickel, PhD principal investigator
Dept. of Psychiatry, Technical University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systematic detection of vascular risk factors and subsequent evidence-based treatment in people with Stroke and Dementia, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of long-term care disability (time frame: 8 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01107548, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2012.