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ISRCTN
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ISRCTN67362546
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ClinicalTrials.gov identifier
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Public title
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The potential role of B-Type natriuretic peptide (BNP) and high-sensitivity troponin t(hs-tnt) pre-screening by GPs to better target rapid access chest pain clinic referrals
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Scientific title
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The potential role of B-Type natriuretic peptide (BNP) and high-sensitivity troponin t(hs-tnt) pre-screening by GPs to better target rapid access chest pain clinic referrals: a prospective observational longitudinal cohort study
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Acronym
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N/A
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Serial number at source
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GEO003
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Study hypothesis
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Rapid access chest pain clinics (RACPCs) are being established throughout the NHS. However they are costly, especially since at least 50% of referrals turn out to have non-cardiac pain. A pre-screening test before RACPC referral might reduce referrals, save money and relieve unnecessary patient anxiety. The pre-screening test which might fulfil this function is B-Type natriuretic peptide (BNP) and high-sensitivity troponin t(hs-tnt). We wish to formally study how accurate a pre-screening test for BNP and high-sensitivity troponin t(hs-tnt) would be in safely identifying that a potential RACPC referral was unnecessary. We will do this by measuring BNP and high-sensitivity troponin t(hs-tnt) in 500 of the patients who are currently referred to the RACPCs in Tayside. We will also see whether BNP and high-sensitivity troponin t(hs-tnt) is able to accurately predict which patients will suffer a cardiovascular event in the year after their RACPC referral. Data in other populations make this appear a very likely prospect. We will also do a full assessment to assess all the other knock on consequences if GPs were to use BNP and high-sensitivity troponin t(hs-tnt) to select their RACPC referrals.
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Lay summary
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Ethics approval
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Tayside Local Research Ethics Committee approved in 10/2005 (ref: 05/S1402/49)
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Study design
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Prospective observational longitudinal cohort study
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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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Cardiac chest pain
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Participants - inclusion criteria
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1. Patients presenting to the rapid Access Chest Pain Clinic with Cardiac Chest Pain
2. Aged 20 - 93 years, both male and female
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Participants - exclusion criteria
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Patients with non-cardiac chest pain
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Anticipated start date
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01/03/2007
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Anticipated end date
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31/08/2009
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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625
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Interventions
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625 patients attending Rapid Access Chest Pain Clinics in Tayside were recruited into the study over a two year period. Each patient had demographic data, a near patient BNP and high-sensitivity troponin t(hs-tnt) level (Biosite®), clinical and laboratory measurements documented. The initial diagnosis was considered positive for ischaemic heart disease (IHD) if the patient had a positive troponin T or was referred for angiography. All patients were then followed up one year after their initial RACPC attendance using hospital medical records, primary care records and telephone calls to document further RACPC attendance, hospitalisations for chest pain and survival data.
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Primary outcome measure(s)
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Negative predictive value of BNP compared to final clinical diagnosis and troponin T result
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Secondary outcome measure(s)
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12 month follow-up for hospital free survival based on initial BNP and high-sensitivity troponin t(hs-tnt) level
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Sources of funding
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Chest Heart and Stroke Scotland (UK) (ref: Res07/A105)
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Trial website
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Publications
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Contact name
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Dr
Jacob
George
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Address
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Department of Clinical Pharmacology
Centre for Cardiovascular and Lung Biology
Mailbox 2, Level 7
Ninewells Hospital
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City/town
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Dundee
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Zip/Postcode
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DD1 9SY
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Country
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United Kingdom
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Tel
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+44 (0)1382 632180
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Fax
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+44 (0)1382 644972
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Email
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j.george@dundee.ac.uk
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Sponsor
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University of Dundee (UK)
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Address
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Nethergate
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City/town
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Dundee
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Zip/Postcode
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DD1 4HN
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Country
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United Kingdom
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Sponsor website:
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http://www.dundee.ac.uk/
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Date applied
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29/12/2009
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Last edited
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31/05/2011
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Date ISRCTN assigned
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06/04/2010
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