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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00805246
First received: December 5, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

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
Pulmonary Embolism

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Identifying CT Imaging Biomarkers Associated With Prognosis of Pulmonary Embolism

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • The clinical and Imaging Biomarkers associated with Pulmonary Embolism (PE). [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pulmonary Embolism (PE) risk prediction rule. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 900
Study Start Date: December 2008
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pulmonary Embolism (PE)
Subjects diagnosed with PE by CT will be recruited.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00805246

Contacts
Contact: Karen M. Pealer, BA, CCRC 412-647-7385 pealerkm@upmc.edu

Locations
United States, Missouri
Washington University in St. Louis Not yet recruiting
St. Louis, Missouri, United States, 63130
Contact: Molly Mohrman, RRT    314-747-4633    mohrmanm@mir.wustl.edu   
Principal Investigator: Pamela K. Woodard, MD         
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Karen M. Pealer, BA, CCRC    412-647-7385    pealerkm@upmc.edu   
Principal Investigator: K. Ty Bae, MD, PhD         
Sub-Investigator: Donald M. Yealy, MD         
Sub-Investigator: Chang Joyce, PhD         
Sub-Investigator: Mark S. Roberts, MD, MPP         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Study Director: Rebecca P. Link, Ph.D. National Heart, Lung, and Blood Institute (NHLBI)
  More Information

No publications provided

Responsible Party: Kyongtae T. Bae, M.D. Ph.D., University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00805246     History of Changes
Other Study ID Numbers: HL095115, HL095115
Study First Received: December 5, 2008
Last Updated: December 5, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Pulmonary embolism
PE
CT
Biomarker
Prognosis
Risk Prediction

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

ClinicalTrials.gov processed this record on October 21, 2014