Condition category
Circulatory System
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
24/05/2016
Prospective/Retrospective
Retrospectively 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

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

http://www.dh.gov.uk/en/index.htm

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

Publication citations

Additional files

Editorial Notes

24/05/2016: No publications found, verifying study status with principal investigator