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ISRCTN
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ISRCTN37477515
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ClinicalTrials.gov identifier
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Public title
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Grid removals vs. dose and image quality for diagnostic imaging on a Innova 2000 cardiac system.
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0050140299
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Study hypothesis
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Demonstrate a reduction in patient exposure/dose commensurate with no negative impact on diagnosis by removing antiscatter grid.
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Lay summary
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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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Coronary artery disease
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Participants - inclusion criteria
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1. Patients referred for diagnosis of coronary artery disease by coronary angiography . 100 2. BMI <40
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Participants - exclusion criteria
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1. Risk of pregnancy
2. Patients with suspected valve disease
3. BMI ≥ 40
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Anticipated start date
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28/01/2004
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Anticipated end date
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28/07/2004
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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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100 recruited locally
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Interventions
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Patients referred for diagnosis of coronary artery disease and with a Body Mass Index of less than 40 will be randomised into two groups. One group will receive the standard technique with grid, the other group will receive the modified (lower skin dose) technique without the grid. Post diagnosis images acquired will be double blindly reviewed for image quality.
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Primary outcome measure(s)
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1. Successful diagnosis of disease
2. Lower skin dose to the patient
3. Lower exposure to members of staff monitored during the trial as the employer is required to do by IRR1999 regulation 8(1)
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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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Bradford Teaching Hospitals NHS Foundation Trust (UK)
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Trial website
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Publications
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No publications intended as of 01/07/10
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Contact name
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Dr
Henry
Lindsay
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Address
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Bradford Cardiology Research Unit
Ward 22
Bradford Royal Infirmary
Duckworth Lane
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City/town
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Bradford
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Zip/Postcode
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BD9 6RJ
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Country
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United Kingdom
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Tel
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+44 (0)1274 364 181
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Fax
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+44 (0)1274 364 741
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Email
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Steven.lindsay@bradfordhospitals.nhs.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2005
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Last edited
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01/07/2010
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Date ISRCTN assigned
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30/09/2005
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