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

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ClinicalTrials.gov Identifier: NCT00880737
Recruitment Status : Completed
First Posted : April 14, 2009
Last Update Posted : June 15, 2011
Sponsor:
Information provided by:
Carlos III Health Institute

Tracking Information
First Submitted Date April 13, 2009
First Posted Date April 14, 2009
Last Update Posted Date June 15, 2011
Study Start Date February 2009
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 13, 2009)
The primary outcome considered will be death by any cause in the month following diagnosis. [ Time Frame: 30 days after PE diagnosis ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prognostic Value of Computed Tomography (CT) Scan in Hemodynamically Stable Patients With Acute Symptomatic Pulmonary Embolism
Official Title Not Provided
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Hemodynamically stable outpatients with suspicion of pulmonary embolism, confirmed by objective testing
Condition Pulmonary Embolism
Intervention Not Provided
Study Groups/Cohorts Stable PE patients
Hemodynamically stable patients with acute symptomatic pulmonary embolism
Publications * Lankeit M, Jiménez D, Kostrubiec M, Dellas C, Kuhnert K, Hasenfuß G, Pruszczyk P, Konstantinides S. Validation of N-terminal pro-brain natriuretic peptide cut-off values for risk stratification of pulmonary embolism. Eur Respir J. 2014 Jun;43(6):1669-77. doi: 10.1183/09031936.00211613. Epub 2014 Mar 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: April 13, 2009)
850
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT00880737
Other Study ID Numbers FIS 2008
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor Carlos III Health Institute
Collaborators Not Provided
Investigators Not Provided
PRS Account Carlos III Health Institute
Verification Date February 2010