Accuracy of the D-Dimer Assay for the Exclusion of Pulmonary Embolism in a High Risk Oncologic Population

Study Overview
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Brief Summary
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The purpose of this study is to see if a blood test (D-dimer) is as precise as the CT scan for the detection of clots. A pulmonary embolism is an obstruction of the blood vessels in your lungs usually due to a blood clot that travels to the lungs usually from the leg. Research has shown that the results of a specific blood test (D-dimer) can be used instead of a CT scan to diagnose clots. D-dimer is a valuable diagnostic marker in either detecting the presence of or monitoring the progress of blood clots. D-dimer assays have proven to be a beneficial diagnostic tool in the evaluation of patients with suspected pulmonary embolism (PE).

Official Title
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Accuracy of the D-Dimer Assay for the Exclusion of Pulmonary Embolism in a High Risk Oncologic Population: A Correlation With Ct Pulmonary Angiogram in the Urgent Care Setting

Conditions
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Cancer, Pulmonary Embolism

Intervention / Treatment
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* Procedure: CT pulmonary angiogram and d-dimer draw


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients evaluated in the urgent care center and determined to need with CT pulmonary angiogram to rule out pulmonary embolism based on signs and symptoms such as dyspnea, pleuritic chest pain, tachycardia, and/or pulse oxygen desaturation will be included. Exclusion Criteria: Inability to obtain CT pulmonary angiogram secondary to lack of IV access, contrast allergy or lack of consent. CT pulmonary angiogram not done with routine protocol for rule out pulmonary embolism. Less than 21 years of age

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients to have a CT pulmonary angiogram for suspected pulmonary embolism will have a d-dimer drawn as is routinely done. | Procedure: CT pulmonary angiogram and d-dimer draw<br>* A CT pulmonary angiogram and a d-dimer drawn within 24 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The negative predictive value of the d-dimer assay relative to CT pulmonary angiogram will be the primary measure of accuracy used for this purpose. |  | conclusion of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the positive predictive value, sensitivity, and specificity of the d-dimer assay relative to CT pulmonary angiogram. |  | conclusion of study | 
| To explore the association between the accuracy of the d-dimer assay and clinical symptoms indicating pulmonary embolism. |  | conclusion of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Any cancer, suspected pulmonary embolism