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

NCT00117169 | Completed

• 2 other identifiers: CT-EP4FNRS, Grant No 3200B0-105988
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Embolism

Keywords

Pulmonary embolism; multi-detector helical computed tomography clinical probability; clinical score

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

• 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

Interventions

multi-detector helical computed tomography PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Geneva University Hospital

Geneva, Canton of Geneva, 1205, Switzerland

Location

Related Publications (5)

• 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. doi: 10.1056/NEJMoa042905.

  PMID: 15858185 BACKGROUND

• Bertoletti L, Le Gal G, Aujesky D, Sanchez O, Roy PM, Verschuren F, Bounameaux H, Perrier A, Righini M. Prognostic value of the Geneva prediction rule in patients with pulmonary embolism. Thromb Res. 2013 Jul;132(1):32-6. doi: 10.1016/j.thromres.2013.05.001. Epub 2013 May 26.

  PMID: 23714176 DERIVED

• 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. doi: 10.1111/j.1538-7836.2008.03264.x. Epub 2008 Dec 20.

  PMID: 19143927 DERIVED

• Vuilleumier N, Le Gal G, 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. doi: 10.1111/j.1538-7836.2008.03260.x.

  PMID: 19087222 DERIVED

• 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. doi: 10.1016/S0140-6736(08)60594-2.

  PMID: 18424324 DERIVED

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Righini MR Marc, Dr

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 30, 2005
• First Posted: July 4, 2005
• Study Start: January 1, 2005
• Study Completion: October 1, 2006
• Last Updated: October 15, 2012

Record last verified: 2012-10

Locations

CH (1)