IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
An Observational Study of Cholesterol in Coronary Arteries (COLOR)
This study has been completed.
Sponsor:
InfraReDx
Information provided by (Responsible Party):
InfraReDx
ClinicalTrials.gov Identifier:
NCT00831116
First received: January 27, 2009
Last updated: June 8, 2017
Last verified: June 2017
| Tracking Information | ||||
|---|---|---|---|---|
| First Received Date ICMJE | January 27, 2009 | |||
| Last Updated Date | June 8, 2017 | |||
| Actual Start Date ICMJE | February 2009 | |||
| Primary Completion Date | February 2016 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures ICMJE |
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 ICMJE | Not Provided | |||
| Change History | Complete list of historical versions of study NCT00831116 on ClinicalTrials.gov Archive Site | |||
| Current Secondary Outcome Measures ICMJE |
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 ICMJE | Not Provided | |||
| Current Other Outcome Measures ICMJE | Not Provided | |||
| Original Other Outcome Measures ICMJE | Not Provided | |||
| Descriptive Information | ||||
| Brief Title ICMJE | An Observational Study of Cholesterol in Coronary Arteries | |||
| Official Title ICMJE | 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 ICMJE | Observational | |||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
|||
| 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 ICMJE |
|
|||
| Intervention ICMJE | Device: Intravascular Near Infrared Spectroscopy
Intravascular imaging with a catheter based spectroscopy system.
Other Name: LipiScan Coronary Imaging System |
|||
| Study Groups/Cohorts | LipiScan
Subjects who have at least one native coronary artery imaged with the LipiScan CIS.
Intervention: Device: Intravascular Near Infrared Spectroscopy |
|||
| Publications * | Not Provided | |||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Enrollment ICMJE | 2067 | |||
| Completion Date | April 2017 | |||
| Primary Completion Date | February 2016 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
| Sex/Gender |
|
|||
| Ages | 18 Years and older (Adult, Senior) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00831116 | |||
| Other Study ID Numbers ICMJE | 0111 | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| Plan to Share Data | Not Provided | |||
| IPD Description | Not Provided | |||
| Responsible Party | InfraReDx | |||
| Study Sponsor ICMJE | InfraReDx | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
|
|||
| PRS Account | InfraReDx | |||
| Verification Date | June 2017 | |||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
||||