An Observational Study of Cholesterol in Coronary Arteries (COLOR)
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ClinicalTrials.gov Identifier: NCT00831116 |
Recruitment Status
:
Completed
First Posted
: January 28, 2009
Last Update Posted
: June 9, 2017
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Sponsor:
InfraReDx
Information provided by (Responsible Party):
InfraReDx
Tracking Information | ||||
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First Submitted Date | January 27, 2009 | |||
First Posted Date | January 28, 2009 | |||
Last Update Posted Date | June 9, 2017 | |||
Actual Study Start Date | February 2009 | |||
Actual Primary Completion Date | February 2016 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
Identify associations of LCP with angiographic or symptomatic presentation of coronary artery disease in a catheterization laboratory population [ Time Frame: after completion of the study - during data analysis ] | |||
Original Primary Outcome Measures | Not Provided | |||
Change History | Complete list of historical versions of study NCT00831116 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures |
Identification of associations that LCP or the Lipid Core Burden Index (LCBI) may have with atherosclerosis appearance, progression, regression, and/or cardiac event [ Time Frame: Upto 2 years post procedure(baseline) ] | |||
Original Secondary Outcome Measures | Not Provided | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | An Observational Study of Cholesterol in Coronary Arteries | |||
Official Title | Chemometric Observation of Lipid Core Plaques of Interest in Native Coronary Arteries Registry | |||
Brief Summary | In April 2008, a coronary catheter based imaging system, LipiScan, was cleared by the FDA for use in detecting lipid core containing containing plaques of interest (LCP). These plaques are rich in cholesterol. The way that cholesterol and other lipids deposit with the coronary artery is unique to each patient. This study is an organized attempt to observe the LCP and the variety of ways that it presents in patients as detected by this recently approved device. This information will be used for physician training and to observe the behavior of the LCP in response to no therapy and currently approved therapies. The purpose of this project is further medical knowledge of the LCP and its treatment. | |||
Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Subjects will be recruited from those presenting or referred to the cardiac catheterization laboratory for elective cardiac catheterization. | |||
Condition |
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Intervention | Device: Intravascular Near Infrared Spectroscopy
Intravascular imaging with a catheter based spectroscopy system.
Other Name: LipiScan Coronary Imaging System |
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Study Groups/Cohorts | LipiScan
Subjects who have at least one native coronary artery imaged with the LipiScan CIS.
Intervention: Device: Intravascular Near Infrared Spectroscopy |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
2067 | |||
Original Estimated Enrollment |
1000 | |||
Actual Study Completion Date | April 2017 | |||
Actual Primary Completion Date | February 2016 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00831116 | |||
Other Study ID Numbers | 0111 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | InfraReDx | |||
Study Sponsor | InfraReDx | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | InfraReDx | |||
Verification Date | June 2017 |