Accuracy of the D-Dimer Assay for the Exclusion of Pulmonary Embolism in a High Risk Oncologic Population
This study has been completed.
Sponsor:
Memorial Sloan-Kettering Cancer Center
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
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Purpose
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 | Intervention |
|---|---|
|
Cancer Pulmonary Embolism |
Procedure: CT pulmonary angiogram and d-dimer draw |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 213 |
| Study Start Date: | May 2005 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
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.
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients coming to MSKCC Urgent care unit
Criteria
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00615147 History of Changes |
| Other Study ID Numbers: | 05-040 |
| Study First Received: | February 1, 2008 |
| Last Updated: | January 6, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
Any cancer suspected pulmonary embolism |
Additional relevant MeSH terms:
|
Embolism Pulmonary Embolism Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Fibrin fragment D |
Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Hemostatics Coagulants Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013