Status:
WITHDRAWN
Clinical Performance Evaluation of the Cholestech LDX Cardiac hsCRP Test (CLEAR)
Lead Sponsor:
Abbott RDx Cardiometabolic
Conditions:
Cardiovascular Disease
Eligibility:
All Genders
18+ years
Brief Summary
This is a multi-center study designed to assess the accuracy and precision of the Cholestech LDX Cardiac hsCRP test for the quantitative determination of C-reactive protein (CRP) in whole blood, serum...
Eligibility Criteria
Inclusion
- Adults (18 years of age or older) presenting to their physician's office or outpatient clinic for routine or pre-scheduled visits and a candidate for cardiovascular risk assessment.
- Willing and able to provide written informed consent and comply with study procedures.
Exclusion
- Known hematocrit \<30% or \> 52%;
- History of medical conditions - other than risk of cardiovascular disease - that may elevate CRP as listed in Appendix B (e.g., tissue damage, infection, inflammation, malignant neoplasia)
- Vulnerable populations deemed inappropriate for study by the site's principal investigator.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00933764
Start Date
August 1 2009
End Date
November 1 2009
Last Update
July 21 2015
Active Locations (2)
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1
St. Joseph's Research Institute
Atlanta, Georgia, United States, 30342
2
Heart and Vascular Research Center of Northern Michigan
Petoskey, Michigan, United States, 49770