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

This study has been completed.
Sponsor:
Information provided by:
Carlos III Health Institute
ClinicalTrials.gov Identifier:
NCT00880737
First received: April 13, 2009
Last updated: June 14, 2011
Last verified: February 2010
History of Changes
  Purpose

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
Pulmonary Embolism

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Carlos III Health Institute:

Primary Outcome Measures:
  • The primary outcome considered will be death by any cause in the month following diagnosis. [ Time Frame: 30 days after PE diagnosis ] [ Designated as safety issue: No ]

Estimated Enrollment: 850
Study Start Date: February 2009
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Stable PE patients
Hemodynamically stable patients with acute symptomatic pulmonary embolism

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hemodynamically stable outpatients with suspicion of pulmonary embolism, confirmed by objective testing

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00880737

Locations
Spain
Ramón y Cajal Hospital
Madrid, Spain, 28034
Sponsors and Collaborators
Carlos III Health Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00880737     History of Changes
Other Study ID Numbers: FIS 2008
Study First Received: April 13, 2009
Last Updated: June 14, 2011
Health Authority: Spain: Ethics Committee

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 19, 2013