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

NCT00880737 | Completed DMC

• 1 other identifier: FIS 2008
• Study Type: observational
• Target: 850
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

• The primary outcome considered will be death by any cause in the month following diagnosis.

  30 days after PE diagnosis

Study Arms (1)

Stable PE patients

Hemodynamically stable patients with acute symptomatic pulmonary embolism

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hemodynamically stable outpatients with suspicion of pulmonary embolism, confirmed by objective testing

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carlos III Health Institute: lead

Study Sites (1)

Ramón y Cajal Hospital

Madrid, 28034, Spain

Location

Related Publications (1)

• Lankeit M, Jimenez 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.

  PMID: 24627529 DERIVED

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: April 13, 2009
• First Posted: April 14, 2009
• Study Start: February 1, 2009
• Primary Completion: June 1, 2011
• Last Updated: June 15, 2011

Record last verified: 2010-02

Locations

ES (1)