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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01126775
Recruitment Status : Unknown
Verified January 2013 by INVADE gGmbH.
Recruitment status was:  Recruiting
First Posted : May 20, 2010
Last Update Posted : January 23, 2013
Information provided by (Responsible Party):

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.

Condition or disease
Stroke Dementia

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : April 2012
Estimated Primary Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

group non-high-risk
group high risk

Primary Outcome Measures :
  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. [ Time Frame: 4/2012 until 11/2013 ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 4/2012 until 11/2013 ]
  2. Detection of microbleedings by MRI in more than 10% of all subjects [ Time Frame: 4/2010 until 11/2011 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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")

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01126775

Contact: Hans Gnahn, Dr.
Contact: Astrid Biermeier

Praxis Dr. Briesenick u. Dr. Förstner Recruiting
Baldham, Bavaria, Germany, D-85598
Contact: Claus Briesenick, Dr.    +49 (0)8106 ext 308866   
Contact: Sabine Förstner, Dr.    +49 (0)8106 ext 308866   
Sub-Investigator: Helmut Ambach, Dr.         
Praxis Dr. Gnahn u. Dr. Klein Recruiting
Ebersberg, Bavaria, Germany, 85560
Contact: Hans Gnahn, Dr.   
Contact: Julia Hartmann, Dr.   
Principal Investigator: Hans Gnahn, Dr.         
Sub-Investigator: Julia Hartmann, Dr.         
Sub-Investigator: Werner Klein, Dr.         
Sponsors and Collaborators

Responsible Party: INVADE gGmbH Identifier: NCT01126775     History of Changes
Other Study ID Numbers: INV-1006-Gna-1000-I
First Posted: May 20, 2010    Key Record Dates
Last Update Posted: January 23, 2013
Last Verified: January 2013

Keywords provided by INVADE gGmbH:
Systematic prevention, stroke, vascular dementia, silent strokes, cerebral microangiopathy.

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders