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Pulmonary embolism diagnosis study
ISRCTN ISRCTN65486961
DOI 10.1186/ISRCTN65486961
ClinicalTrials.gov identifier
EudraCT number
Public title Pulmonary embolism diagnosis study
Scientific title
Acronym N/A
Serial number at source MCT-44150
Study hypothesis 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.
Lay summary
Ethics approval Ethics approval received from the Queen Elizabeth II Health Sciences Centre Research Ethics Committee on the 8th March 2001.
Study design Randomised controlled trial
Countries of recruitment Canada
Disease/condition/study domain Pulmonary embolism (PE)
Participants - inclusion criteria 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.
Participants - exclusion criteria 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
Anticipated start date 01/11/2005
Anticipated end date 31/07/2006
Status of trial Completed
Patient information material
Target number of participants 1530
Interventions 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
Primary outcome measure(s) Symptomatic venous thromboembolism.
Secondary outcome measure(s) 1. Asymptomatic venous thromboembolism
2. Death
3. Bleed (major and minor)
Sources of funding Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-44150)
Trial website
Publications Results in http://www.ncbi.nlm.nih.gov/pubmed/18165667
Contact name Dr  David Robert  Anderson
  Address Queen Elizabeth II Health Science Centre
VGH Site, Room 430
Bethune Building
1278 Tower Road
  City/town Halifax
  Zip/Postcode B3H 2Y9
  Country Canada
  Tel +1 902 473 8562
  Fax +1 902 473 4600
  Email david.anderson@dal.ca
Sponsor Queen Elizabeth II Health Science Centre (Nova Scotia) (Canada)
  Address 1278 Tower Road
  City/town Halifax
  Zip/Postcode B3H 2Y9
  Country Canada
  Email Susan.Pleasance@cdha.nshealth.ca
Date applied 26/09/2005
Last edited 21/04/2008
Date ISRCTN assigned 26/09/2005
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