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Swiss Atrial Fibrillation Cohort Study (SWISS-AF)

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ClinicalTrials.gov Identifier: NCT02105844
Recruitment Status : Active, not recruiting
First Posted : April 7, 2014
Last Update Posted : February 15, 2018
Sponsor:
Collaborators:
Swiss National Science Foundation
Medical Image Analysis Center (MIAC) Basel
Schiller AG Baar
Clinical Trial Unit, University Hospital Basel, Switzerland
Cardiovascular Research Institute (CRIB) Basel
Cardiocentro Ticino
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.


Condition or disease
Atrial Fibrillation

Study Type : Observational
Actual Enrollment : 2415 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Swiss Atrial Fibrillation Cohort Study - SWISS AF
Actual Study Start Date : March 2014
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Atrial Fibrillation
Cohort Study on patients with atrial fibrillation in Switzerland



Primary Outcome Measures :
  1. Stroke or systemic embolism [ Time Frame: 2018 (after an average of 2.5 years of follow-up) ]

Secondary Outcome Measures :
  1. Hospitalization for heart failure [ Time Frame: 2018 (after an average of 2.5 years of follow-up) ]

Biospecimen Retention:   Samples With DNA
samples with DNA


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients with atrial fibrillation
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105844


Locations
Switzerland
University Hospital
Basel, Basel-Stadt, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Swiss National Science Foundation
Medical Image Analysis Center (MIAC) Basel
Schiller AG Baar
Clinical Trial Unit, University Hospital Basel, Switzerland
Cardiovascular Research Institute (CRIB) Basel
Cardiocentro Ticino
Investigators
Study Director: Stefan Osswald, MD, Prof. University Hospital, Basel, Switzerland
Principal Investigator: Michael Kuehne, MD, PD, exec. MBA University Hospital, Basel, Switzerland
Principal Investigator: David Conen, MD MPH McMaster University, Population Health Research Institute, Hamilton, Canada

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02105844     History of Changes
Other Study ID Numbers: SWISS-AF
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018

Keywords provided by University Hospital, Basel, Switzerland:
atrial fibrillation
dementia
cognitive dysfunction
stroke
Magnetic resonance imaging

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes