NCT00357227

Brief Summary

B8: Atrial fibrillation and the risk of neurological complications Twenty-five thousand acute strokes are caused by atrial fibrillation every year. But even more frequent than symptomatic strokes are silent infarctions of the brain. Silent strokes remain undetected in most cases, but cumulate over time and progressively impair cognition. The impact of atrial fibrillation on subacute brain infarctions is not yet known. Moreover, it has not been elucidated so far how effective different therapeutic strategies in the treatment of atrial fibrillation prevent cognitive impairment. Thus, this study aims at evaluating the influence of different types of atrial fibrillation on silent strokes and the related impairment in cognitive functions. Other risk factors and cardiovascular diseases that are known to provoke the development of strokes will be assessed as well. So, it will be possible to isolate the contribution of atrial fibrillation to silent strokes and related cognitive impairment in segregation to other relevant factors. AF patients and controls will be examined twice in two years in order to evaluate the role of atrial fibrillation and differential therapeutic interventions with regard to the progression of silent strokes and cognitive impairment in a within subject-design.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2006

Completed
Last Updated

April 19, 2007

Status Verified

April 1, 2007

First QC Date

July 25, 2006

Last Update Submit

April 18, 2007

Conditions

Keywords

Atrial fibrillationStrokeVascular DementiaMild Cognitive Impairment

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of permanent, paroxysmal or episodic atrial fibrillation in the past or at present

You may not qualify if:

  • Pacemaker
  • Metal implants
  • History of acute stroke
  • Diagnosis of vascular or degenerative dementia
  • History of brain tumors
  • History of severe brain injury
  • History of psychiatric disorders
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Münster, Dept. of Neurology

Münster, North Rhine-Westphalia, 48149, Germany

RECRUITING

MeSH Terms

Conditions

Atrial FibrillationStrokeDementia, VascularCognitive Dysfunction

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesIntracranial ArteriosclerosisIntracranial Arterial DiseasesDementiaLeukoencephalopathiesArteriosclerosisArterial Occlusive DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Officials

  • Stefan Knecht, Prof.

    University Hospital Münster, Department of Neurology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Knecht, Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 25, 2006

First Posted

July 27, 2006

Study Start

January 1, 2004

Last Updated

April 19, 2007

Record last verified: 2007-04

Locations