Pulmonary Embolism Clinical Trial
Official title:
Identifying CT Imaging Biomarkers Associated With Prognosis of Pulmonary Embolism
NCT number | NCT00805246 |
Other study ID # | HL095115 |
Secondary ID | HL095115 |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | December 2008 |
Est. completion date | May 2017 |
Verified date | June 2017 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 910 |
Est. completion date | May 2017 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
United States | Washington University in St. Louis | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The clinical and Imaging Biomarkers associated with Pulmonary Embolism (PE). | 5 years | ||
Secondary | Pulmonary Embolism (PE) risk prediction rule. | 5 years |
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