Clinical Performance Evaluation of the Cholestech LDX Cardiac hsCRP Test (CLEAR)



Status:Withdrawn
Conditions:Peripheral Vascular Disease
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:August 2009
End Date:November 2009

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Trial Summary
Trial Overview
Inclusion Criteria

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 and plasma from individuals being assessed for risk of cardiovascular
disease. The Cholestech LDX Cardiac hsCRP test consists of the CRP cassette and LDX analyzer
and measures CRP with high sensitivity on fingerstick or venous whole blood at the
point-of-care (POC). The results of this study are intended to be used for regulatory 510k
filings for use as an in vitro diagnostic test.


Inclusion Criteria:

1. 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.

2. Willing and able to provide written informed consent and comply with study
procedures.

Exclusion Criteria:

1. Known hematocrit <30% or > 52%;

2. 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)

3. Vulnerable populations deemed inappropriate for study by the site's principal
investigator.
We found this trial at
2
sites
Heart and Vascular Research Center of Northern Michigan
Petoskey, Michigan 49770
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Petoskey, MI
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St. Joseph's Research Institute
Atlanta, Georgia 30342
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Atlanta, GA
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