Pulmonary Embolism Clinical Trial
— PROTECTNCT number | NCT00880737 |
Other study ID # | FIS 2008 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | April 13, 2009 |
Last updated | June 14, 2011 |
Start date | February 2009 |
Verified date | February 2010 |
Source | Carlos III Health Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Ethics Committee |
Study type | Observational |
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.
Status | Completed |
Enrollment | 850 |
Est. completion date | |
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Spain | Ramón y Cajal Hospital | Madrid |
Lead Sponsor | Collaborator |
---|---|
Carlos III Health Institute |
Spain,
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 |
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