Clinical Performance Evaluation of the Cholestech LDX Cardiac hsCRP Test (CLEAR) (CLEAR)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00933764 |
Recruitment Status
:
Withdrawn
First Posted
: July 7, 2009
Last Update Posted
: July 21, 2015
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Condition or disease |
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Cardiovascular Disease |
Study Type : | Observational |
Actual Enrollment : | 0 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Study Start Date : | August 2009 |
Estimated Primary Completion Date : | October 2009 |
Estimated Study Completion Date : | November 2009 |

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00933764
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 |
Responsible Party: | Meghan Bigelow / Clinical Trial Manager, Inverness Medical Innovations |
ClinicalTrials.gov Identifier: | NCT00933764 History of Changes |
Other Study ID Numbers: |
BSTE-0113 |
First Posted: | July 7, 2009 Key Record Dates |
Last Update Posted: | July 21, 2015 |
Last Verified: | July 2015 |
Additional relevant MeSH terms:
Cardiovascular Diseases |