Accuracy of the D-Dimer Assay for the Exclusion of Pulmonary Embolism in a High Risk Oncologic Population
|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: NCT00615147|
Recruitment Status : Completed
First Posted : February 14, 2008
Last Update Posted : January 9, 2012
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).
|Condition or disease||Intervention/treatment|
|Cancer Pulmonary Embolism||Procedure: CT pulmonary angiogram and d-dimer draw|
|Study Type :||Observational|
|Actual Enrollment :||213 participants|
|Official Title:||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|
|Study Start Date :||May 2005|
|Primary Completion Date :||June 2008|
|Study Completion Date :||June 2008|
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
A CT pulmonary angiogram and a d-dimer drawn within 24 hours.
- 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. [ Time Frame: conclusion of study ]
- To estimate the positive predictive value, sensitivity, and specificity of the d-dimer assay relative to CT pulmonary angiogram. [ Time Frame: conclusion of study ]
- To explore the association between the accuracy of the d-dimer assay and clinical symptoms indicating pulmonary embolism. [ Time Frame: conclusion of study ]
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): NCT00615147
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|