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|
|Actual Primary Completion Date :||June 2008|
|Actual 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 ]
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|