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

Stroke Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01126775
• Other study ID #: INV-1006-Gna-1000-I
• Status: Recruiting
• Phase: N/A
• First received: May 18, 2010
• Last updated: January 22, 2013
• Start date: April 2012

Study information

• Verified date: January 2013
• Source: INVADE gGmbH
• Contact: Hans Gnahn, Dr.
• Email: hans[@]gnahn.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. primary completion date: November 2013
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dementia
• Stroke

Locations

Country	Name	City	State
Germany	Praxis Dr. Briesenick u. Dr. Förstner	Baldham	Bavaria
Germany	Praxis Dr. Gnahn u. Dr. Klein	Ebersberg	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
INVADE gGmbH

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Detection of microbleedings by MRI in more than 10% of all subjects		4/2010 until 11/2011