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ISRCTN
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ISRCTN19633732
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ClinicalTrials.gov identifier
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Public title
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Randomised controlled trial and cost effectiveness study of targeted screening versus systematic population screening for atrial fibrillation in the over 65s: the SAFE study.
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Scientific title
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Acronym
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SAFE
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Serial number at source
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HTA 96/22/11
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Study hypothesis
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1. To establish the incremental cost effectiveness of different screening options (targeted or population screening) compared with routine clinical practice for detection of AF in over 65s.
2. To determine the value of clinical factors and echocardiography in the process of risk stratification for thromboembolic disease in patients with AF.
3. To determine optimal method of AF diagnosis and ECG interpretation.
4. To assess implications for service provision should screening for AF become a national programme.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Cardiovascular diseases: Heart disease
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Participants - inclusion criteria
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Patients over 65 years
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Participants - exclusion criteria
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Not provided at time of registration.
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Anticipated start date
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01/06/2000
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Anticipated end date
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31/05/2003
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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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15,000
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Interventions
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Screening vs control.
24,000 patients aged over 65 will be identified from approximately 24 purposefully selected general practices from the West Midlands. Patient randomisation will result in 5,000 patients invited for screening with 5,000 control patients from the same practice (Principal-control patients). Control practices will provide a further 4,000 control patients (Practice-controls). Prospective identification of pre-existing risk factors for AF within the screened population (estimated at 2,000 patients) will enable comparison between high risk targeted screening and total population screening. Study outcomes will identify the clinical and cost effectiveness of overall screening strategy (2 options compared), actual screening method (4 methods compared), and screening test interpretation (4 options evaluated).
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Primary outcome measure(s)
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Not provided at time of registration.
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Secondary outcome measure(s)
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Not provided at time of registration.
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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http://www.anticoagulation.org.uk/safe.htm#top
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Publications
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Results in:
1. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15283871
2. http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=17673732
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Contact name
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Prof
FD Richard
Hobbs
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Address
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Department of Primary Care & General Practice
University of Birmingham
The Medical School
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City/town
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Birmingham
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Zip/Postcode
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B15 2TT
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Country
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United Kingdom
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Tel
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+44 (0)121 415 8019
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Fax
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+44 (0)121 414 3050
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Email
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f.d.r.hobbs@bham.ac.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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25/04/2003
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Last edited
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11/01/2008
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Date ISRCTN assigned
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25/04/2003
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