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

Pulmonary Embolism Clinical Trial

— PROTECT  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00880737
• Other study ID #: FIS 2008
• Status: Completed
• Phase: N/A
• First received: April 13, 2009
• Last updated: June 14, 2011
• Start date: February 2009

Study information

• Verified date: February 2010
• Source: Carlos III Health Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 850
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Embolism
• Pulmonary Embolism

Locations

Country	Name	City	State
Spain	Ramón y Cajal Hospital	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Carlos III Health Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome considered will be death by any cause in the month following diagnosis.		30 days after PE diagnosis	No