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PROTECT: Prognostic Value of Computed Tomography (CT) Scan in Hemodynamically Stable Patients With Acute Symptomatic Pulmonary Embolism

Sponsor
Carlos III Health Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00880737
Collaborator
(none)
850
Enrollment
1
Location

Study Details

Study Description

Brief Summary

The objectives of the PROTECT study are:

  • To assess the role of CT pulmonary angiography in the risk stratification of hemodynamically stable patients with acute symptomatic pulmonary embolism (PE).

  • To assess the role of transthoracic echocardiography in the risk stratification of hemodynamically stable patients with acute symptomatic PE.

  • To assess the role of 2 biomarkers (troponin and brain natriuretic peptide) in the risk stratification of hemodynamically stable patients with acute symptomatic PE.

  • To assess the role of the Pulmonary Embolism Severity Index (PESI) in the risk stratification of hemodynamically stable patients with acute symptomatic PE.

  • To assess the combined role of CT pulmonary angiography, transthoracic echocardiography, PESI, troponin I and brain natriuretic peptide in the risk stratification of hemodynamically stable patients with acute symptomatic PE.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    850 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Study Start Date :
    Feb 1, 2009
    Actual Primary Completion Date :
    Jun 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    Stable PE patients

    Hemodynamically stable patients with acute symptomatic pulmonary embolism

    Outcome Measures

    Primary Outcome Measures

    1. The primary outcome considered will be death by any cause in the month following diagnosis. [30 days after PE diagnosis]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Acute symptomatic Pulmonary Embolism (PE) confirmed by:

    • CT pulmonary angiography positive for PE

    • Ventilation/ perfusion lung scan with high likelihood of PE (according to PIOPED criteria)

    • V/Q ventilation/ perfusion lung scan inconclusive for PE or negative CT pulmonary angiography in a patient with thoracic symptoms and a lower limb ultrasound showing a positive diagnosis for deep vein thrombosis.

    Exclusion Criteria:

    • Contraindication for CT pulmonary angiography (allergy to iodine contrasts or creatinin clearance < 30 ml/min).

    • Informed consent not obtained.

    • Pregnancy.

    • Life expectancy of less than 3 months.

    • Hemodynamic unstability defined as SBP < 90 mm Hg, need for cardiopulmonary reanimation, need for vasoactive drugs or orotracheal intubation.

    • Thrombectomy, insertion of filter in the cava vein, or need for fibrinolytic treatment for PE episode.

    • Participation in another clinical trial for treatment of PE.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ramón y Cajal Hospital Madrid Spain 28034

    Sponsors and Collaborators

    • Carlos III Health Institute

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00880737
    Other Study ID Numbers:
    • FIS 2008
    First Posted:
    Apr 14, 2009
    Last Update Posted:
    Jun 15, 2011
    Last Verified:
    Feb 1, 2010
    Additional relevant MeSH terms:
    Pulmonary Embolism
    Embolism

    Study Results

    No Results Posted as of Jun 15, 2011