Multi-Detector Spiral Computed Tomography Alone Versus Combined Strategy With Lower Limb Compression Ultrasonography in Outpatients Suspected of Pulmonary Embolism
|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.|
|ClinicalTrials.gov Identifier: NCT00117169|
Recruitment Status : Completed
First Posted : July 4, 2005
Last Update Posted : October 15, 2012
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 or disease||Intervention/treatment||Phase|
|Pulmonary Embolism||Procedure: multi-detector helical computed tomography||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||1500 participants|
|Intervention Model:||Parallel Assignment|
|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]|
|Study Start Date :||January 2005|
|Study Completion Date :||October 2006|
- The primary outcome variable will be the number of thromboembolic events in the 3-month follow-up period in each group.
- 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
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
|Geneva University Hospital|
|Geneva, Switzerland, 1205|
|Principal Investigator:||Righini MR Marc, Dr||University Hospital, Geneva|