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

This study is currently recruiting participants.
Verified August 2012 by INVADE gGmbH
Sponsor:
Information provided by (Responsible Party):
INVADE gGmbH
ClinicalTrials.gov Identifier:
NCT01126775
First received: May 18, 2010
Last updated: October 9, 2012
Last verified: August 2012
History of Changes
  Purpose

"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
Stroke
Dementia

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:

MedlinePlus related topics: Dementia
U.S. FDA Resources

Further study details as provided by INVADE gGmbH:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 1000
Study Start Date: April 2012
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
group non-high-risk
group high risk

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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")

Criteria

Inclusion Criteria:

  • Participation in INVADE-2-study
  • signed informed consent
  • no contraindication for MRI-examination

Exclusion Criteria:

  • Contraindication for MRI-examination
  • claustrophobia
  • history of clinical apparent stroke or cerebral bleeding
  • lack of consent in being told incidental findings
  • lack of capacity to consent in study participation
  • lack of capacity to cooperate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01126775

Contacts
Contact: Hans Gnahn, Dr. hans@gnahn.de
Contact: Julia Hartmann, Dr. hartmann@invade.de

Locations
Germany
Praxis Dr. Briesenick u. Dr. Förstner Recruiting
Baldham, Bavaria, Germany, D-85598
Contact: Claus Briesenick, Dr.     +49 (0)8106 ext 308866     praxis@neuro-baldham.de    
Contact: Sabine Förstner, Dr.     +49 (0)8106 ext 308866     praxis@neuro-baldham.de    
Sub-Investigator: Helmut Ambach, Dr.            
Praxis Dr. Gnahn u. Dr. Klein Recruiting
Ebersberg, Bavaria, Germany, 85560
Contact: Hans Gnahn, Dr.         hans@gnahn.de    
Contact: Julia Hartmann, Dr.         hartmann@invade.de    
Principal Investigator: Hans Gnahn, Dr.            
Sub-Investigator: Julia Hartmann, Dr.            
Sub-Investigator: Werner Klein, Dr.            
Sponsors and Collaborators
INVADE gGmbH
  More Information

Publications:

Responsible Party: INVADE gGmbH
ClinicalTrials.gov Identifier: NCT01126775     History of Changes
Other Study ID Numbers: INV-1006-Gna-1000-I
Study First Received: May 18, 2010
Last Updated: October 9, 2012
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Dementia
Stroke
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 17, 2012