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Validation of Different Risk Assessment Strategies in Normotensive Pulmonary Embolism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02843243
Recruitment Status : Unknown
Verified January 2017 by Azienda Ospedaliera Cosenza.
Recruitment status was:  Recruiting
First Posted : July 25, 2016
Last Update Posted : January 24, 2017
Sponsor:
Information provided by (Responsible Party):
Azienda Ospedaliera Cosenza

Brief Summary:
A risk stratification in hemodynamically stable patients with acute pulmonary embolism (PE) is deemed necessary to guide patient management. With the aim to improve the positive predictive value (PPV) for PE-related adverse events in in normotensive patients, a number of scores combining multiple risk-factors have been published. In addition, an algorithm for the risk-stratification of patients with PE has been proposed by the European society of cardiology. None but one of these scores underwent external and prospective validation. The aim of this study is to externally and prospectively validate the PPV for PE-related adverse events of the Bova score and modified FAST score in a large multicenter cohort.

Condition or disease
Pulmonary Embolism

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Multicenter Validation of Different Risk Assessment Strategies in Normotensive Patients With Acute Pulmonary Embolism
Study Start Date : December 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Adverse events PE-related [ Time Frame: within 30 days from the hospital admission ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients aged 18 years or older with Pulmonary Embolism and hemodynamic stability (that is, SBP 90 mm Hg or more)
Criteria

Inclusion Criteria:

Pulmonary Embolism with hemodynamic stability (that is, SBP 90 mm Hg or more)

Exclusion Criteria:

Refuse of informed consent


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843243


Contacts
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Contact: Carlo Bova, MD 0984681401 ext +39 carbova@libero.it

Locations
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Italy
Azienda ospedaliera Cosenza Recruiting
Cosenza, Italy, 87100
Contact: Carlo Bova, MD    0984681401 ext +39    carbova@libero.it   
Sponsors and Collaborators
Azienda Ospedaliera Cosenza
Investigators
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Principal Investigator: Carlo Bova, MD Azienda Ospedaliera Cosenza
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Responsible Party: Azienda Ospedaliera Cosenza
ClinicalTrials.gov Identifier: NCT02843243    
Other Study ID Numbers: bova 1 protocol
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases