Neuro-Prävention im Rahmen Des Interventionsprojektes INVADE-2 (Follow-up Studie)

• Conditions: Stroke; Dementia

• Registration Number: NCT01126775
• Lead Sponsor: INVADE gGmbH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-18
• Study First Submitted QC: 2010-05-19
• Study First Posted: 2010-05-20
• Study Start: 2012-04
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-22
• Last Update Posted: 2013-01-23
• Primary Completion: 2013-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Praxis Dr. Gnahn u. Dr. Klein; 🇩🇪 Ebersberg, Bavaria, Germany

Praxis Dr. Briesenick u. Dr. Förstner; 🇩🇪 Baldham, Bavaria, Germany