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

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind
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:

MedlinePlus related topics: CT Scans Pulmonary Embolism

U.S. FDA Resources

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

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Perrier A, Roy PM, Sanchez O, Le Gal G, Meyer G, Gourdier AL, Furber A, Revel MP, Howarth N, Davido A, Bounameaux H. Multidetector-row computed tomography in suspected pulmonary embolism. N Engl J Med. 2005 Apr 28;352(17):1760-8.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Righini M, Le Gal G, Aujesky D, Roy PM, Sanchez O, Verschuren F, Kossovsky M, Bressollette L, Meyer G, Perrier A, Bounameaux H. Complete venous ultrasound in outpatients with suspected pulmonary embolism. J Thromb Haemost. 2009 Mar;7(3):406-12. Epub 2008 Dec 20.

Vuilleumier N, Le Gal L, Verschuren F, Perrier A, Bounameaux H, Turck N, Sanchez JC, Mensi N, Perneger T, Hochstrasser D, Righini M. Cardiac biomarkers for risk stratification in non-massive pulmonary embolism: a multicenter prospective study. J Thromb Haemost. 2009 Mar;7(3):391-8.

Righini M, Le Gal G, Aujesky D, Roy PM, Sanchez O, Verschuren F, Rutschmann O, Nonent M, Cornuz J, Thys F, Le Manach CP, Revel MP, Poletti PA, Meyer G, Mottier D, Perneger T, Bounameaux H, Perrier A. Diagnosis of pulmonary embolism by multidetector CT alone or combined with venous ultrasonography of the leg: a randomised non-inferiority trial. Lancet. 2008 Apr 19;371(9621):1343-52.

ClinicalTrials.gov Identifier:	NCT00117169 History of Changes
Other Study ID Numbers:	CT-EP4, FNRS, Grant No 3200B0-105988
Study First Received:	June 30, 2005
Last Updated:	October 12, 2012
Health Authority:	Switzerland: Swissmedic

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

ClinicalTrials.gov processed this record on May 21, 2013