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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00933764

Acronym

CLEAR

Enrollment

Registered

2009-07-07

Start date

2009-08-31

Completion date

2009-11-30

Last updated

2015-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Disease

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 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Countries

United States

Outcome results