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Multi-Detector Spiral Computed Tomography Alone Versus Combined Strategy With Lower Limb Compression Ultrasonography in Outpatients Suspected of Pulmonary Embolism

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00117169
First Posted: July 4, 2005
Last Update Posted: October 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Geneva
  Purpose

The main hypothesis for this study is that the diagnostic approach of pulmonary embolism (PE) by evaluation of clinical probability, D-dimer test dosage and multi-detector helical computed tomography (hCT) is as safe as the classical "approach" using clinical probability, D-dimer test, lower limb compression ultrasonography and multi-detector helical computed tomography.

The second hypothesis involves evaluating the role of searching distal, i.e. infrapopliteal, deep venous thromboses (DVTs) in the diagnostic approach of pulmonary embolism.


Condition Intervention
Pulmonary Embolism Procedure: multi-detector helical computed tomography

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: Multi-Detector Spiral Computed Tomography Alone Versus Combined Strategy With Lower Limb Compression Ultrasonography in Outpatients Suspected of Pulmonary Embolism: A Randomised Non-Inferiority Trial [CTEP4]

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • The primary outcome variable will be the number of thromboembolic events in the 3-month follow-up period in each group.

Secondary Outcome Measures:
  • Costs incurred in each study arm. (Costs will be directly measured and will represent direct costs, not charges. Measurements will include all costs due to diagnosis of PE, including the costs associated with the length of stay in the emergency ward)
  • Classification performances of the revised Geneva standardised clinical score, as assessed by its capacity to distinguish patients having low, intermediate and high probability of PE
  • Proportion of patients in whom hCT could have been avoided by using the presence of a distal DVT to rule in the diagnosis of PE (proportion of patients with both distal DVT on ultrasonography and PE on multi-detector hCT)
  • Proportion of patients with distal DVT on ultrasonography but without pulmonary embolism on multi-detector hCT and without thromboembolic event during the 3 months follow-up

Estimated Enrollment: 1500
Study Start Date: January 2005
Estimated Study Completion Date: October 2006
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All outpatients admitted to the emergency ward for suspected pulmonary embolism, defined as acute onset of new or worsening shortness of breath or chest pain without another obvious etiology, will be included in the study, provided they meet all other criteria and they have signed an informed consent form.

Exclusion Criteria:

  • PE suspicion raised more than 24 hours after admission to the hospital
  • Absence of informed consent
  • Life expectancy of less than 3 months
  • Geographic inaccessibility for follow-up
  • Pregnancy
  • Patients anticoagulated for a disease other than venous thromboembolism (for instance, atrial fibrillation)
  • Patients allergic to contrast medium
  • Impaired renal function (creatinine clearance less than 30 ml/min, as calculated by the Cockroft formula)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00117169


Locations
Switzerland
Geneva University Hospital
Geneva, Switzerland, 1205
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Righini MR Marc, Dr Geneva University Hospital
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00117169     History of Changes
Other Study ID Numbers: CT-EP4
FNRS, Grant No 3200B0-105988
First Submitted: June 30, 2005
First Posted: July 4, 2005
Last Update Posted: October 15, 2012
Last Verified: October 2012

Keywords provided by University Hospital, Geneva:
Pulmonary embolism
multi-detector helical computed tomography clinical probability
clinical score

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases