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

Cardiovascular Disease Clinical Trial

— CLEAR  

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00933764
• Other study ID #: BSTE-0113
• Status: Withdrawn
• Phase: N/A
• First received: July 3, 2009
• Last updated: July 20, 2015
• Start date: August 2009
• Est. completion date: November 2009

Study information

• Verified date: July 2015
• Source: Biosite
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Locations

Country	Name	City	State
United States	St. Joseph's Research Institute	Atlanta	Georgia
United States	Heart and Vascular Research Center of Northern Michigan	Petoskey	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Biosite

Country where clinical trial is conducted

United States,