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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Carlos III Health Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 August 28, 2014