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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00880737

Acronym

PROTECT

Enrollment

850

Registered

2009-04-14

Start date

2009-02-28

Completion date

Unknown

Last updated

2011-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Embolism

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
The primary outcome considered will be death by any cause in the month following diagnosis.	30 days after PE diagnosis

Countries

Spain

Outcome results