Atrial FibrillationNCT00357227
Atrial Fibrillation and the Risk for Neurological Complications
An observational study of Atrial Fibrillation, run by University Hospital Muenster at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2004to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of permanent, paroxysmal or episodic atrial fibrillation in the past or at present
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Münster, Dept. of Neurology
Münster, North Rhine-Westphalia, 48149
Stefan Knecht, Prof.
About this study
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.
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Stroke, Vascular Dementia, Mild Cognitive Impairment
- Medical subject headings
- Atrial Fibrillation, Stroke, Dementia, Vascular, Cognitive Dysfunction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2006 (estimated)
- Study startJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 1,000 participants
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Investigators
- Stefan Knecht, Prof., Principal investigator, University Hospital Münster, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00357227
- Sponsor's protocol ID
- 01 GI 0204
- Status last verified
- Apr 2007
- First submitted
- 25 Jul 2006
- Last updated
- 19 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial Fibrillation and the Risk for Neurological Complications
- ClinicalTrials.gov ID
- NCT00357227
- Acronym / sponsor ID
- 01 GI 0204
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Stroke, Vascular Dementia, Mild Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Jan 2004
- First posted
- 27 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of permanent, paroxysmal or episodic atrial fibrillation in the past or at present
Key exclusion criteria (8 listed)
- Pacemaker
- Metal implants
- History of acute stroke
- Diagnosis of vascular or degenerative dementia
- History of brain tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2007.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Knecht, Prof. principal investigator
University Hospital Münster, Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefan Knecht, Prof. (+49-251-83- ext. 48195, knecht@uni-muenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2007.