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

Carlos III Health Institute

Status: Completed

Conditions: Pulmonary Embolism

Study type: Observational

Funder types: Other

Identifiers

NCT00880737

FIS 2008

Details and patient eligibility

About

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.

Enrollment: 850 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

850 participants in 1 patient group

Stable PE patients

Description:

Hemodynamically stable patients with acute symptomatic pulmonary embolism