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ISRCTN
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ISRCTN46104198
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ClinicalTrials.gov identifier
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Public title
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Biomarker-supported detection of paroxysmal atrial fibrillation in patients with cerebral ischemia.
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Scientific title
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A longitudinal cohort study in patients presenting with acute cerebral ischemia to identify factors that are predictive individually or in combination for a diagnosis of atrial fibrillation during 12 months of follow-up.
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Acronym
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Find-AF
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Serial number at source
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Protocol 23/11/08 EC UMG
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Study hypothesis
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Novel biomarkers will improve the diagnosis of paroxysmal atrial fibrillation in patients presenting with cerebral ischemia.
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Lay summary
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Ethics approval
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Approved by local ethics committee of the medical faculty of the university of Goettingen, Germany, on the 27th of January 2009 (ref: 23/11/08)
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Study design
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Single centre observational longitudinal cohort study
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Cerebral ischemia, Atrial fibrillation
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Participants - inclusion criteria
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1. Cerebral ischemia, i.e. transient ischemic attack (TIA) or stroke
2. Ability and willingness to consent
3. Age > 18 years
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Participants - exclusion criteria
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1. Inability or unwillingness to consent
2. Age < 18 years
3. Cerebral haemorrhage
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Anticipated start date
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01/03/2009
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Anticipated end date
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28/02/2011
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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300 included
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Interventions
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Serial biomarker sampling for the identification of novel biomarkers to be used in the diagnosis of atrial fibrillation.
Blood samples will be collected at 0, 6 and 12 hours after presentation. The primary marker will be the value of the change of natriuretic peptides over time after presentation, calculated as ratio N-terminal pro B-type Natriuretic Peptide (NT-proBNP) at 0h / NT-proBNP at 24h.
All patients will also undergo transthoracic echocardiography.
7-day Holter monitoring, 90-day telephone follow-up and 12 months clinical follow-up will be used to optimize detection of atrial fibrillation as the endpoint for which blood markers, clinical characteristics and echocardiographic markers may show prognostic value.
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Primary outcome measure(s)
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Diagnosis of atrial fibrillation from baseline up to 12 months follow-up
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Secondary outcome measure(s)
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Major adverse cerebral or cardiovascular events (MACCE)
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Sources of funding
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University Hospital Goettingen (Germany) - Department of Cardiology and Pneumology
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Trial website
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Publications
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2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20966415
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Contact name
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Dr
Raoul
Stahrenberg
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Address
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Department of Cardiology and Pneumology
University Hospital Goettingen
Robert-Koch-Str. 40
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City/town
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Goettingen
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Zip/Postcode
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37075
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Country
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Germany
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Email
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stahrenberg@med.uni-goettingen.de
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Sponsor
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University Hospital Goettingen (Germany) - Department of Cardiology and Pneumology
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Address
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Robert-Koch-Str. 40
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City/town
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Goettingen
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Zip/Postcode
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37075
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Country
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Germany
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Email
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wachter@med.uni-goettingen.de
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Sponsor website:
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http://www.herzzentrum-goettingen.de
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Date applied
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04/01/2010
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Last edited
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05/11/2010
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Date ISRCTN assigned
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17/02/2010
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