Condition category
Circulatory System
Date applied
26/09/2005
Date assigned
26/09/2005
Last edited
21/04/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr David Robert Anderson

ORCID ID

Contact details

Queen Elizabeth II Health Science Centre
VGH Site
Room 430
Bethune Building
1278 Tower Road
Halifax
B3H 2Y9
Canada
+1 902 473 8562
david.anderson@dal.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCT-44150

Study information

Scientific title

Acronym

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Pulmonary embolism (PE)

Intervention

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

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Symptomatic venous thromboembolism.

Secondary outcome measures

1. Asymptomatic venous thromboembolism
2. Death
3. Bleed (major and minor)

Overall trial start date

01/11/2005

Overall trial end date

31/07/2006

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1530

Participant 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

Recruitment start date

01/11/2005

Recruitment end date

31/07/2006

Locations

Countries of recruitment

Canada

Trial participating centre

Queen Elizabeth II Health Science Centre
Halifax
B3H 2Y9
Canada

Sponsor information

Organisation

Queen Elizabeth II Health Science Centre (Nova Scotia) (Canada)

Sponsor details

1278 Tower Road
Halifax
B3H 2Y9
Canada
Susan.Pleasance@cdha.nshealth.ca

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-44150)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/18165667

Publication citations

  1. Results

    Anderson DR, Kahn SR, Rodger MA, Kovacs MJ, Morris T, Hirsch A, Lang E, Stiell I, Kovacs G, Dreyer J, Dennie C, Cartier Y, Barnes D, Burton E, Pleasance S, Skedgel C, O'Rouke K, Wells PS, Computed tomographic pulmonary angiography vs ventilation-perfusion lung scanning in patients with suspected pulmonary embolism: a randomized controlled trial., JAMA, 2007, 298, 23, 2743-2753, doi: 10.1001/jama.298.23.2743.

Additional files

Editorial Notes