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ISRCTN
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ISRCTN65486961
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ClinicalTrials.gov identifier
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Public title
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Pulmonary embolism diagnosis study
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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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MCT-44150
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Study hypothesis
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We hypothesise that relying on the use of spiral Computed Tomography (CT) as opposed to V/Q scanning as the initial pulmonary imaging procedure to exclude the diagnosis of PE will result in similar rates of subsequent venous thromboembolic events and will be cost-effective.
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Ethics approval
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Ethics approval received from the Queen Elizabeth II Health Sciences Centre Research Ethics Committee on the 8th March 2001.
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Study design
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Randomised controlled trial
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Pulmonary embolism (PE)
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Participants - inclusion criteria
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Consecutive adult patients (18 years and older) of either sex, presenting with symptoms or signs suspected by a physician of being caused by acute pulmonary embolism (acute onset of new or worsening shortness of breath, chest pain, hemoptysis, presyncope or syncope) will be potentially eligible for this study.
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Participants - exclusion criteria
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1. Deep vein thrombosis or pulmonary embolism within the previous 3 months
2. No worsening of the severity of pulmonary symptoms within the previous 2 weeks
3. Use of therapeutic doses of parenteral anticoagulants for greater than 48 hours
4. Co-morbid condition making life expectancy less than 3 months
5. Contradiction to contrast media
6. A need for long-term use of anticoagulants
7. Pregnancy
8. Age less than 18 years
9. Refusal to give informed consent
10. Geographic inaccessibility to follow-up
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Anticipated start date
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01/11/2005
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Anticipated end date
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31/07/2006
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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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1530
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Interventions
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Clinical model to identify PE likely or unlikely, Ddimer blood test, randomised to receive either V/Q or CT for diagnosis of possible PE, in majority of cases would have ultrasound to rule out deep vein thrombosis.
Trial details received: 12 September 2005
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Primary outcome measure(s)
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Symptomatic venous thromboembolism.
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Secondary outcome measure(s)
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1. Asymptomatic venous thromboembolism
2. Death
3. Bleed (major and minor)
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Sources of funding
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Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-44150)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/18165667
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Contact name
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Dr
David Robert
Anderson
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Address
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Queen Elizabeth II Health Science Centre
VGH Site, Room 430
Bethune Building
1278 Tower Road
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City/town
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Halifax
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Zip/Postcode
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B3H 2Y9
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Country
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Canada
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Tel
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+1 902 473 8562
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Fax
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+1 902 473 4600
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Email
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david.anderson@dal.ca
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Sponsor
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Queen Elizabeth II Health Science Centre (Nova Scotia) (Canada)
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Address
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1278 Tower Road
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City/town
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Halifax
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Zip/Postcode
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B3H 2Y9
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Country
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Canada
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Email
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Susan.Pleasance@cdha.nshealth.ca
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Date applied
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26/09/2005
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Last edited
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21/04/2008
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Date ISRCTN assigned
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26/09/2005
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