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Assessing the Prognosis of Pulmonary Embolism Using Clinical and Imaging Biomarkers (Retrospective & Prospective )

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ClinicalTrials.gov Identifier: NCT00805246
Recruitment Status : Active, not recruiting
First Posted : December 9, 2008
Last Update Posted : October 27, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:

Venous thromboembolism (VTE), which clinically manifests as deep vein thrombosis (DVT) and pulmonary embolism (PE), is a common but elusive illness that can cause significant disability and death if not promptly diagnosed and effectively treated. The annual incidence of VTE in the United States is estimated at 1 per 1000. Death occurs in approximately 12% of PE cases within 1 month of diagnosis. At present, clinical management of VTE and PE is hampered by gaps in our understanding of pathogenic mechanisms, the wide variety in patient populations, and incomplete understanding of the long term risks of recurrence and death. Given the complex presentation and risk associated with these conditions, proper risk assessment and subsequent prophylaxis for all at-risk patients is crucial. While clinical prediction rules have been recently developed to associate short-term risks and to stratify patients with acute PE, there is a dearth of objective biomarkers that can be related to the long-term prognosis of the disease. In addition to clinical information, clot burden is known to be strongly associated with clinical outcome of recurrent VTE. The quantification of clot burden requires imaging.

CT Pulmonary Angiography (CTPA) has been established as a reference imaging standard in the diagnosis of PE. In addition to its role as a superb diagnostic tool, CTPA contains a wealth of information including characteristics of the clot that may be used as biomarkers associated with prognosis of PE. The work proposed in this application takes advantage of widely available CTPA imaging biomarker data and extends and advances clinical PE risk prediction model to include long term (2-year) survival as well as the clinically important outcome of recurrence. The primary objective of this proposal is to develop and identify CTPA imaging biomarkers that are associated with short-term and long-term prognoses of patients who were positively diagnosed for PE by CT. The rationale for this proposal is that CT imaging is a rich source of imaging biomarkers that may be associated with prognosis of PE. This information will help advance our understanding of the risk and recurrence of PE and provide a new insight to prognosis and clinical management and treatment of PE. This proposed research is innovative in that we have developed new CT imaging biomarkers and designed a clinical trial to assess and validate the prognostic values of these biomarkers. Our central hypothesis is that CT imaging biomarkers are associated with the risk of death and recurrence in patients with PE. The specific aims of this proposal are: (1) to quantify and characterize pulmonary emboli (volume and distribution) and comorbid cardiovasculopulmonary findings from CT images of patients who were positively diagnosed for PE by CT; (2) to identify CT imaging biomarkers that are associated with the prognosis of patients who were positively diagnosed for PE by CT, and to develop risk prediction tools for death and recurrence; and (3) to prospectively validate the risk prediction tool, and identify whether the change in CT imaging biomarkers of PE after initiation of therapy improve the predictive ability for recurrence and death.

Condition or disease
Pulmonary Embolism

Study Design

Study Type : Observational
Actual Enrollment : 910 participants
Observational Model: Cohort
Official Title: Identifying CT Imaging Biomarkers Associated With Prognosis of Pulmonary Embolism
Study Start Date : December 2008
Primary Completion Date : July 2013
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Pulmonary Embolism (PE)
Subjects diagnosed with PE by CT will be recruited.

Outcome Measures

Primary Outcome Measures :
  1. The clinical and Imaging Biomarkers associated with Pulmonary Embolism (PE). [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Pulmonary Embolism (PE) risk prediction rule. [ Time Frame: 5 years ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults > 18 years of age who either present to University of Pittsburgh Medical Center (UPMC) or Washington University in St. Louis hospitals with acute PE or develop acute PE while admitted to the hospital diagnosed by CT.

Inclusion Criteria:

  1. Adult > 18 years of age who either present to either hospital with acute PE or develop acute PE while admitted to the hospital diagnosed by CT
  2. Capable of informed consent

Exclusion Criteria:

  1. Contraindication to CT scanning
  2. Cannot provide written informed consent.
  3. Patients do not speak English, or have dementia and do not have a proxy who could participate in follow-up interviews.
  4. Pregnant or lactating females.
Contacts and Locations

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): NCT00805246

United States, Missouri
Washington University in St. Louis
St. Louis, Missouri, United States, 63130
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Study Director: Rebecca P. Link, Ph.D. National Heart, Lung, and Blood Institute (NHLBI)
More Information

Responsible Party: Kyongtae Ty Bae, M.D., Ph.D., Professor of Radiology and Bioengineering, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00805246     History of Changes
Other Study ID Numbers: HL095115
First Posted: December 9, 2008    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: January 2016

Keywords provided by Kyongtae Ty Bae, M.D., Ph.D., University of Pittsburgh:
Pulmonary embolism
Risk Prediction

Additional relevant MeSH terms:
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases