Neuro-Prävention im Rahmen Des Interventionsprojektes INVADE-2 (Follow-up Studie)
1 other identifier
observational
1,000
1 country
2
Brief Summary
"Silent" strokes are more frequent than clinical apparent strokes and can be detected noninvasively by MRI-investigations of the brain. Persons with silent strokes have a considerably increased risk for clinical apparent strokes as well as for the development of dementia. Intention of the study is the detection of silent strokes and microbleedings by standardized cranial MRI in 1000 participants (500 high-risk and 500 low-risk persons for cerebrovascular accidents) after a standardized neurological and neuropsychological examination. Results will be the base of early detection and early preventive strategies of cerebrovascular accidents in high-risk persons. In the course of a systematic follow-up examination without MRI the same 1000 patients (500 high-risk and 500 low-risk persons for cerebrovascular accidents) will be reinvited to the sites. In addition to the standardized neurological and neuropsychological examinations a surrogate parameter of nephropathy, microalbumin, will be examined as this parameter could be helpful in forecasting cerebral microangiopathy. The clinical investigation will be expanded by several tests in order to assess symptoms of cerebral microangiopathy.
Trial Health
Trial Health Score
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participants targeted
Target at P75+ for all trials
2 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2010
CompletedFirst Posted
Study publicly available on registry
May 20, 2010
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedJanuary 23, 2013
January 1, 2013
1.6 years
May 18, 2010
January 22, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
In the group of high-risk persons the percentage of silent strokes detected by MRI of the brain is significantly higher than in the group of non-high-risk persons.
4/2012 until 11/2013
Secondary Outcomes (2)
Detection of silent strokes by MRI in more than 10% of all subjects and diagnostic and therapeutic procedures refinancable near-term and in relation to long-term-consequences
4/2012 until 11/2013
Detection of microbleedings by MRI in more than 10% of all subjects
4/2010 until 11/2011
Study Arms (2)
group non-high-risk
group high risk
Eligibility Criteria
1000 participants of INVADE-2-study ("Intervention project on cerebrovascular diseases and dementia in the district of Ebersberg, Bavaria")
You may qualify if:
- signed informed consent for NPV-2
- ongoing participation in INVADE-2
- completed participation in Neuroprävention study (NPV-1)
You may not qualify if:
- not completed Neuroprävention study (Drop-out)
- disagreement of notification of incidental findings
- lack of capacity to consent of study participant
- lack of willingness to cooperate of study participant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- INVADE gGmbHlead
Study Sites (2)
Praxis Dr. Briesenick u. Dr. Förstner
Baldham, Bavaria, D-85598, Germany
Praxis Dr. Gnahn u. Dr. Klein
Ebersberg, Bavaria, 85560, Germany
Related Publications (1)
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.
PMID: 12486573BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2010
First Posted
May 20, 2010
Study Start
April 1, 2012
Primary Completion
November 1, 2013
Last Updated
January 23, 2013
Record last verified: 2013-01