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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by INVADE gGmbH.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01126775
First Posted: May 20, 2010
Last Update Posted: January 23, 2013
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.
Information provided by (Responsible Party):
INVADE gGmbH
May 18, 2010
May 20, 2010
January 23, 2013
April 2012
November 2013   (Final data collection date for primary outcome 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. [ Time Frame: 4/2012 until 11/2013 ]
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: 4/2010 until 11/2010 ]
Complete list of historical versions of study NCT01126775 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Detection of microbleedings by MRI in more than 10% of all subjects [ Time Frame: 4/2010 until 11/2011 ]
  • Detection of silent strokes by MRI in more than 10% of all subjects diagnostic and therapeutic procedures refinancable near-term and in relation to long-term-consequen-ces [ Time Frame: 4/2010 until 11/2010 ]
  • Detection of microbleedings by MRI in more than 10% of all subjects [ Time Frame: 4/2010 until 11/2010 ]
Not Provided
Not Provided
 
Neuro-Prävention im Rahmen Des Interventionsprojektes INVADE-2 (Follow-up Studie)
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.

"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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
1000 participants of INVADE-2-study ("Intervention project on cerebrovascular diseases and dementia in the district of Ebersberg, Bavaria")
  • Stroke
  • Dementia
Not Provided
  • group non-high-risk
  • group high risk
Scherpinski U, Bickel H, Gnahn H, Förstl 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. German.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
1000
Not Provided
November 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
55 Years and older   (Adult, Senior)
Not Provided
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01126775
INV-1006-Gna-1000-I
No
Not Provided
Not Provided
INVADE gGmbH
INVADE gGmbH
Not Provided
Not Provided
INVADE gGmbH
January 2013