An Observational Study of Cholesterol in Coronary Arteries (COLOR)
This study is currently recruiting participants.
Verified October 2012 by InfraReDx
Sponsor:
InfraReDx
Information provided by (Responsible Party):
InfraReDx
ClinicalTrials.gov Identifier:
NCT00831116
First received: January 27, 2009
Last updated: October 11, 2012
Last verified: October 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Myocardial Infarction Angina Coronary Artery Disease Myocardial Ischemia |
Device: Intravascular Near Infrared Spectroscopy |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Chemometric Observation of Lipid Core Plaques of Interest in Native Coronary Arteries Registry |
Resource links provided by NLM:
Further study details as provided by InfraReDx:
| Estimated Enrollment: | 2000 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | August 2015 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
LipiScan
Subjects who have at least one native coronary artery imaged with the LipiScan CIS.
|
Device: Intravascular Near Infrared Spectroscopy
Intravascular imaging with a catheter based spectroscopy system.
Other Name: LipiScan Coronary Imaging System
|
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
Subjects will be recruited from those presenting or referred to the cardiac catheterization laboratory for elective cardiac catheterization.
Criteria
Inclusion Criteria:
- Subject is at least 18 years of age.
- Subject is scheduled for elective coronary catheterization.
- LipiScan CIS, LipiScan IVUS Imaging System, or TVC Imaging System use is not contra-indicated.
- At least one chemogram from a native coronary artery is available for submission to the registry.
- Able to read, understand and sign the informed consent.
Exclusion Criteria:
- Subject is pregnant or nursing.
- Subject life expectancy is less than 2 years at time of index catheterization.
- All submitted chemograms are obtained with the LipiScan, LipiScan IVUS, or TVC(R) Imaging Catheter positioned within a coronary artery bypass graft.
- Unable to give informed consent
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00831116
Contacts
| Contact: Priti Shah | 1-888-680-7339 ext 646 | pshah@infraredx.com |
Locations
| United States, Arizona | |
| Mercy Gilbert Medical Center | Recruiting |
| Gilbert, Arizona, United States, 85297 | |
| Contact: Stephanie Wells 480-728-9978 stephanie.wells@chw.edu | |
| Contact: Ann Cambpell, RN, BSN 480-728-7086 ann.campbell@chw.edu | |
| Principal Investigator: Nabil Dib, MD | |
| Scottsdale Healthcare | Recruiting |
| Scottsdale, Arizona, United States, 85260 | |
| Contact: Joann Saczynski, RN, MSN jsaczynski@shc.org | |
| Principal Investigator: David Rizik, MD | |
| United States, California | |
| University of California, Los Angeles Medical Center | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Ladda Douangvila 310-794-4797 ldouangvila@mednet.ucla.edu | |
| Principal Investigator: Jon Tobis, MD | |
| University of California Irvine Medical Center | Recruiting |
| Orange, California, United States, 92868 | |
| Contact: Beth Michel, RN emichel@uci.edu | |
| Principal Investigator: Pranav Patel, MD | |
| San Francisco Veterans Affairs Medical Center | Recruiting |
| San Francisco, California, United States, 94121 | |
| Contact: Kathleen Stanley, RN 415-221-4810 ext 4220 kathleen.stanley@va.gov | |
| Principal Investigator: Kendrick Shunk, MD,PhD | |
| United States, Florida | |
| University of Florida, Gainesville | Recruiting |
| Gainesville, Florida, United States, 32610 | |
| Contact: Heather Herndon, RN heather.herndon@medicine.ufl.edu | |
| Contact: Dana Leach, RN dana.leach@medicine.ufl.edu | |
| Principal Investigator: Carl J Pepine, MD | |
| Pepin Heart Hospital | Recruiting |
| Tampa, Florida, United States, 33613 | |
| Contact: Abugail Snow Abigail.Snow@AHSS.ORG | |
| Principal Investigator: Charles Lambert | |
| United States, Georgia | |
| Piedmont Hospital | Recruiting |
| Atlanta, Georgia, United States, 30309 | |
| Contact: Laura Murrieta, BS,RD 404-605-3074 laura.murrieta@piedmont.org | |
| Principal Investigator: William L Ballard, MD | |
| United States, Maryland | |
| Washington Adventist Hospital | Recruiting |
| Takoma Park, Maryland, United States, 20912 | |
| Contact: Dawn E Shaddinger, RN, MSN 301-891-5612 dshaddin@adventisthealthcare.com | |
| Contact: Denise Pond, RN dpond@ahm.com | |
| Principal Investigator: Fayaz Shawl, MD | |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Contact: Catherine B Troy 617-632-7766 ctroy@bidmc.harvard.edu | |
| Principal Investigator: Donald Cutlip, MD | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Iris McNulty, RN 617-726-2612 imcnulty@partners.org | |
| Principal Investigator: Ik-Kyung Jang, MD, PhD | |
| Lahey Clinic | Recruiting |
| Burlington, Massachusetts, United States, 01803 | |
| Contact: Judy Pendleton 781-744-7512 Judy.E.Pendleton@lahey.org | |
| Principal Investigator: Thomas Piemonte | |
| United States, Michigan | |
| Crittenton Shelton Heart Center: | Recruiting |
| Rochester Hills, Michigan, United States, 48307 | |
| Contact: Elias H, Boueiri 248-652-5156 eboueiri@Crittenton.com | |
| Principal Investigator: Samer Kazziha | |
| William Beaumont Hospital | Recruiting |
| Royal Oak, Michigan, United States, 48073 | |
| Contact: Dorothy Richardson 248-898-9161 drichardson@beaumont.edu | |
| Principal Investigator: Simon R Dixon, MD | |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Cindy M Woltman, RN 507-266-4095 woltman.cindy@mayo.edu | |
| Principal Investigator: Amir Lerman, MD | |
| United States, Missouri | |
| Saint Louis University Hospital | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Elizabeth Weber, RN, MSN 314-577-8876 eweber1@slu.edu | |
| Contact: Christine Uhles, RN, BSN 314-577-8876 ctaaffe1@slu.edu | |
| Principal Investigator: Michael J Lim, MD | |
| United States, New York | |
| Mount Sinai School of Medicine | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Michael Fusilero michael.fusilero@mountsinai.org | |
| Principal Investigator: Annapoorna S Kini, MD | |
| Sub-Investigator: Pedro Moreno, MD | |
| Columbia Universtiy Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Fernando Sosa fas2123@columbia.edu | |
| Principal Investigator: Giora Weisz, MD | |
| United States, Pennsylvania | |
| Pinnacle Heart & Vascular Institute | Recruiting |
| Harrisburg, Pennsylvania, United States, 17101 | |
| Contact: Anita Todd, RN research@moffittheart.com | |
| Contact: Tammy Whittaker, NR-CMA research@moffittheart.com | |
| Principal Investigator: Brijeshwar Maini, MD | |
| United States, South Carolina | |
| Medical University of South Carolina Hospital | Recruiting |
| Charleston, South Carolina, United States, 29403 | |
| Contact: Christina M Russell, RN 843-876-5008 russelcm@musc.edu | |
| Principal Investigator: Eric R Powers, MD | |
| United States, Texas | |
| Veterans Affairs, North Texas Health Care Systems | Recruiting |
| Dallas, Texas, United States, 75216 | |
| Contact: Holly Wise 214-857-1415 holly.wise@va.gov | |
| Contact: Bavana Rangan bavana.rangan@va.gov | |
| Principal Investigator: Emmanouil S Brilakis, MD,PhD | |
| Sub-Investigator: Subhash Banerjee, MD | |
| United States, Washington | |
| Swedish Medical Center | Recruiting |
| Seattle, Washington, United States, 98122 | |
| Contact: Jennifer Nagel 206-386-6462 jennifer.nagel@swedish.org | |
| Principal Investigator: John L Petersen, MD | |
| Principal Investigator: Mark Reisman, MD | |
Sponsors and Collaborators
InfraReDx
Investigators
| Study Chair: | Giora Weisz, MD | Columbia University |
More Information
No publications provided
| Responsible Party: | InfraReDx |
| ClinicalTrials.gov Identifier: | NCT00831116 History of Changes |
| Other Study ID Numbers: | 0111 |
| Study First Received: | January 27, 2009 |
| Last Updated: | October 11, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by InfraReDx:
|
near infrared spectroscopy LipiScan lipid core percutaneous coronary intervention |
myocardial infarction NIRS intravascular imaging |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Infarction Ischemia Myocardial Infarction Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Pathologic Processes Necrosis |
ClinicalTrials.gov processed this record on October 18, 2012
