NCT00933764

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2009

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 7, 2009

Completed
25 days until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

July 21, 2015

Status Verified

July 1, 2015

Enrollment Period

2 months

First QC Date

July 3, 2009

Last Update Submit

July 20, 2015

Conditions

Cardiovascular Disease

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St. Joseph's Research Institute

Atlanta, Georgia, 30342, United States

Location

Heart and Vascular Research Center of Northern Michigan

Petoskey, Michigan, 49770, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Cardiovascular Diseases
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 3, 2009

First Posted

July 7, 2009

Study Start

August 1, 2009

Primary Completion

October 1, 2009

Study Completion

November 1, 2009

Last Updated

July 21, 2015

Record last verified: 2015-07

Locations

US(2)