Contact information
Type
Scientific
Primary contact
Prof Alan Moody
ORCID ID
Contact details
Department of Medical Imaging
Sunnybrook & Women's Health Sciences Centre
Ontario
2075 Bayview Avenue
Toronto
Ontario
M4N 3M5
Canada
-
alan.moody@sunnybrook.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 96/07/03
Study information
Scientific title
A randomised trial comparing four methods of investigating patients with suspected pulmonary thrombo-embolism
Acronym
Study hypothesis
Diagnosis of pulmonary thrombo-embolus is problematic and there have been recent calls for a change in diagnostic strategy.
We intend to investigate the diagnostic effectiveness and cost effectiveness, by studying confidence of diagnosis, and the cost benefit, by studying three month outcome measures (recurrence, complications of treatment, morbidity and mortality), of four imaging protocols in patients suspected of pulmonary thrombo-embolus randomised to these protocols. Results will provide data regarding efficient diagnostic stratagems guiding cost-effective patient management and influencing future capital expenditure.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Cardiovascular diseases: Thromboembolic disease
Intervention
A randomised, open clinical trial in a single centre of four investigational protocols: patients are randomised into one of the protocols.
1. V/Q scan +/- lower limb doppler ultrasound +/- clinical assessment of risk
2. V/Q scan +/- lower limb doppler ultrasound +/- conventional pulmonary angiography
3. Contrast enhanced volumetric Computed Tomography (CT) +/- lower limb doppler ultrasound
4. Pulmonary and lower limb Magnetic Resonance Imaging (MRI)
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Follow-up will monitor: Days in hospital. Other investigations. Treatment costs. Recurrent thrombo-embolic disease in three months following investigation. Readmission and subsequent costs.
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
01/04/1999
Overall trial end date
31/03/2002
Reason abandoned
Eligibility
Participant inclusion criteria
Patients suspected of acute pulmonary embolus normally investigated with ventilation-perfusion (V/Q) radionucleide scanning. 18 years or greater. Giving informed consent.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration.
Participant exclusion criteria
Unable to give informed consent. Pregnant. Contraindication to any one of the above protocols.
Recruitment start date
01/04/1999
Recruitment end date
31/03/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Medical Imaging
Ontario
M4N 3M5
Canada
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
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