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OpenTrials
Completed

NCT Number: NCT00880737

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ramón y Cajal Hospital

Madrid, 28034, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 30 days after PE diagnosis

Sponsors and collaborators

Lead sponsor

Carlos III Health Institute

Other Gov

Registry information

Acronym: PROTECT

Important dates

Study start
2009
Primary completion
2011
First posted
Apr 14, 2009
Registry last updated
Jun 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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