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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00615147
First received: February 1, 2008
Last updated: January 6, 2012
Last verified: January 2012

February 1, 2008
January 6, 2012
May 2005
June 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00615147 on ClinicalTrials.gov Archive Site
  • To estimate the positive predictive value, sensitivity, and specificity of the d-dimer assay relative to CT pulmonary angiogram. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
  • To explore the association between the accuracy of the d-dimer assay and clinical symptoms indicating pulmonary embolism. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Accuracy of the D-Dimer Assay for the Exclusion of Pulmonary Embolism in a High Risk Oncologic Population
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

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).

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients coming to MSKCC Urgent care unit

  • Cancer
  • Pulmonary Embolism
Procedure: CT pulmonary angiogram and d-dimer draw
A CT pulmonary angiogram and a d-dimer drawn within 24 hours.
1
Patients to have a CT pulmonary angiogram for suspected pulmonary embolism will have a d-dimer drawn as is routinely done.
Intervention: Procedure: CT pulmonary angiogram and d-dimer draw
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
213
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00615147
05-040
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Not Provided
Memorial Sloan-Kettering Cancer Center
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP