Clinical trial NCT01126775: Neuro-Prävention im Rahmen Des Interventionsprojektes INVADE-2 (Follow-up Studie)
Official title: Neuro-Prävention im Rahmen Des Interventionsprojektes INVADE-2 Systematische Prävention Bei Hochrisikopatienten für Schlaganfall Und vaskulär (Mit)Bedingte Demenz: Identifizierung Und Behandlung Von Stummen Hirninfarkten.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Dementia
Keywords: Systematic prevention, stroke, vascular dementia, silent strokes, cerebral microangiopathy.
Lead sponsor: INVADE gGmbH
Sponsor class: OTHER
First posted: 2010-05-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1000 participants of INVADE-2-study ("Intervention project on cerebrovascular diseases and dementia in the district of Ebersberg, Bavaria")

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.


Eligibility criteria: Inclusion Criteria:

* signed informed consent for NPV-2
* ongoing participation in INVADE-2
* completed participation in Neuroprävention study (NPV-1)

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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.
timeFrame: 4/2012 until 11/2013
Secondary outcomes:
measure: 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
timeFrame: 4/2012 until 11/2013
measure: Detection of microbleedings by MRI in more than 10% of all subjects
timeFrame: 4/2010 until 11/2011
Other outcomes:
Locations:
city: Baldham
country: Germany
facility: Praxis Dr. Briesenick u. Dr. Förstner
state: Bavaria
city: Ebersberg
country: Germany
facility: Praxis Dr. Gnahn u. Dr. Klein
state: Bavaria
Study officials:
References:
citation: 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.