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

NCT ID: NCT01126775

Last Updated: 2013-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Brief Summary

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"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

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Conditions

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Stroke Dementia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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group non-high-risk

No interventions assigned to this group

group high risk

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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INVADE gGmbH

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Praxis Dr. Briesenick u. Dr. Förstner

Baldham, Bavaria, Germany

Site Status RECRUITING

Praxis Dr. Gnahn u. Dr. Klein

Ebersberg, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Hans Gnahn, Dr.

Role: CONTACT

Astrid Biermeier

Role: CONTACT

Facility Contacts

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Claus Briesenick, Dr.

Role: primary

+49 (0)8106 ext. 308866

Sabine Förstner, Dr.

Role: backup

+49 (0)8106 ext. 308866

Hans Gnahn, Dr.

Role: primary

Julia Hartmann, Dr.

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 12486573 (View on PubMed)

Other Identifiers

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INV-1006-Gna-1000-I

Identifier Type: -

Identifier Source: org_study_id

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