Clinical trial NCT02105844: Swiss Atrial Fibrillation Cohort Study
Official title: Swiss Atrial Fibrillation Cohort Study - SWISS AF
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
dementia
cognitive dysfunction
stroke
Magnetic resonance imaging
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
name: Medical Image Analysis Center (MIAC) Basel
name: Schiller AG Baar
name: Clinical Trial Unit, University Hospital Basel, Switzerland
name: Cardiovascular Research Institute (CRIB) Basel
name: Cardiocentro Ticino
First posted: 2014-04-07
Enrollment: 2415
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients with atrial fibrillation

Brief summary: Swiss-AF is a prospective observational, multicentric cohort study in Switzerland. Overall, 2600 patients with documented atrial fibrillation aged \>65 years will be included and followed on a yearly basis.

Yearly clinical examinations include a detailed questionnaire on personal characteristics, a resting electrocardiogram, neurocognitive function tests and questionnaires on disability and quality of life. Blood sampling and brain magnetic resonance imaging are scheduled at baseline and after 2 years of follow-up.

The main study aims of this long term prospective study are to increase our knowledge on structural brain damage and its changes over time in patients with atrial fibrillation, to gain additional insights on the incidence and underlying mechanisms of cognitive decline in patients with atrial fibrillation and to evaluate the interrelationships of structural and functional brain damage in this population.


Eligibility criteria: Inclusion Criteria:

* atrial fibrillation documented within the last 24 months
* age \>=45 years

Exclusion Criteria:

* acute illness
* inability to provide informed consent
* Only short episodes of reversible forms of atrial fibrillation

Primary outcomes:
measure: Stroke or systemic embolism
timeFrame: 2018 (after an average of 2.5 years of follow-up)
Secondary outcomes:
measure: Hospitalization for heart failure
timeFrame: 2018 (after an average of 2.5 years of follow-up)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital
state: Basel-Stadt
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Stefan Osswald, MD, Prof.
role: STUDY_DIRECTOR
affiliation: University Hospital, Basel, Switzerland
name: Michael Kuehne, MD, PD, exec. MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University, Population Health Research Institute, Hamilton, Canada
name: David Conen, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
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