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ISRCTN
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ISRCTN38976321
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ClinicalTrials.gov identifier
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Public title
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The TASCFORCE Project: Tayside Screening For risk of Cardiac Events and the effect of statin on risk reduction
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Scientific title
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Acronym
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TASCFORCE
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Serial number at source
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Protocol no.: TASC07; MHRA: 020807
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Study hypothesis
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That screening an at risk population by magnetic resonance imaging for early signs of heart disease as measured by left ventricular mass combined with a statin intervention in the high risk group will prevent heart attack stroke and the associated mortality.
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Lay summary
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Ethics approval
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Tayside Committee on Medical Research Ethics B. Date of approval: 13/07/2007 (ref: 07/S1402/42)
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Study design
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Double-blind, randomised, placebo-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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Prevention of cardiovascular events in at-risk population
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Participants - inclusion criteria
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Men and women aged 40 years and over
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Participants - exclusion criteria
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1. Known atherosclerotic disease
2. Indication for Statin therapy according to current clinical practice
3. Known primary muscle disease
4. Contraindication to statin
5. Any serious illness that may compromise the subjects safety or completion of study
6. Any illness which means that the subject is unable to give informed consent
7. Known alcohol abuse
8. Drinking more than two glasses of grapefruit juice per day
9. Pregnancy and not using reliable method of contraception
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Anticipated start date
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01/06/2007
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Anticipated end date
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31/05/2011
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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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5000
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Interventions
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Simvastatin 40 mg daily versus placebo for 18 months to 2 years, and then all participants will receive life style counselling and leaflets on modifiable risk factors at one 15-minute session.
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Primary outcome measure(s)
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Left ventricular mass at two years.
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Secondary outcome measure(s)
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Validation of the Magnetic Resonance Imaging (MRI) screening tool as a predictor of cardiovascular disease.
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Sources of funding
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Chest, Heart and Stroke Scotland (UK)
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Trial website
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Publications
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Contact name
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Prof
Jill
Belch
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Address
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The Institute of Cardiovascular Research
Vascular and Inflammatory Diseases Research Unit
Ninewells Hospital and Medical School
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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 632457
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Fax
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+44 (0)1382 632333
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Email
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j.j.f.belch@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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c/o Mr James Houston
Research and Innovation Services
University of Dundee
11 Perth Road
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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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Tel
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+44 (0)1382 384664
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Fax
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+44 (0)1382 202178
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Email
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j.z.houston@dundee.ac.uk
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Date applied
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02/04/2007
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Last edited
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12/09/2008
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Date ISRCTN assigned
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05/06/2007
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