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

This study has been terminated.

Sponsor:

Information provided by:

Biosite

ClinicalTrials.gov Identifier:

NCT00933764

First received: July 3, 2009

Last updated: April 14, 2010

Last verified: April 2010

History of Changes

Purpose

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.

Condition
Cardiovascular Disease


Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective

Further study details as provided by Biosite:

Biospecimen Retention: Samples Without DNA

Plasma and Serum samples will be retained for reference testing and banking.


Estimated Enrollment:	190
Study Start Date:	August 2009
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Individuals being assessed of their risk of cardiovascular disease. Patients can currently be diagnosed with cardiovascular disease.

Criteria

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00933764

Locations


United States, Georgia
St. Joseph's Research Institute
Atlanta, Georgia, United States, 30342
United States, Michigan
Heart and Vascular Research Center of Northern Michigan
Petoskey, Michigan, United States, 49770

Sponsors and Collaborators

Biosite

More Information

No publications provided


Responsible Party:	Meghan Bigelow / Clinical Trial Manager, Inverness Medical Innovations
ClinicalTrials.gov Identifier:	NCT00933764 History of Changes
Other Study ID Numbers:	BSTE-0113
Study First Received:	July 3, 2009
Last Updated:	April 14, 2010
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on March 03, 2015

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