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.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01126775

Enrollment

1000

Registered

2010-05-20

Start date

2012-04-30

Completion date

Unknown

Last updated

2013-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia, Stroke

Keywords

Systematic prevention, stroke, vascular dementia, silent strokes, cerebral microangiopathy.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

55 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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
Detection of microbleedings by MRI in more than 10% of all subjects	4/2010 until 11/2011

Countries

Germany

Contacts

Primary ContactHans Gnahn, Dr.

hans@gnahn.de

Backup ContactAstrid Biermeier

biermeier@invade.de

Outcome results