Myocardial InfarctionCOLORNCT00831116
An Observational Study of Cholesterol in Coronary Arteries
An observational study of Myocardial Infarction and Angina, run by Infraredx at 22 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, Angina, Coronary Artery Disease
- What is being tested?
- Intravascular Near Infrared Spectroscopy
- Type of treatment
- Medical device
- How many people
- 2,067 participants
- Where
- 22 sitesUnited States
- Study dates
- Feb 2009to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be recruited from those presenting or referred to the cardiac catheterization laboratory for elective cardiac catheterization.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Piedmont Hospital
Atlanta, Georgia, 30309
Massachusetts General Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Lahey Clinic
Burlington, Massachusetts, 01803
Medical University of South Carolina Hospital
Charleston, South Carolina, 29403
Veterans Affairs, North Texas Health Care Systems
Dallas, Texas, 75216
University of Florida, Gainesville
Gainesville, Florida, 32610
Mercy Gilbert Medical Center
Gilbert, Arizona, 85297
Pinnacle Heart & Vascular Institute
Harrisburg, Pennsylvania, 17101
University of California, Los Angeles Medical Center
Los Angeles, California, 90095
Mount Sinai School of Medicine
New York, New York, 10029
Columbia Universtiy Medical Center
New York, New York, 10032
University of California Irvine Medical Center
Orange, California, 92868
Mayo Clinic
Rochester, Minnesota, 55905
Crittenton Shelton Heart Center:
Rochester Hills, Michigan, 48307
William Beaumont Hospital
Royal Oak, Michigan, 48073
San Francisco Veterans Affairs Medical Center
San Francisco, California, 94121
Scottsdale Healthcare
Scottsdale, Arizona, 85260
Swedish Medical Center
Seattle, Washington, 98122
Saint Louis University Hospital
St Louis, Missouri, 63110
Washington Adventist Hospital
Takoma Park, Maryland, 20912
Pepin Heart Hospital
Tampa, Florida, 33613
About this study
Official title: Chemometric Observation of Lipid Core Plaques of Interest in Native Coronary Arteries Registry
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.
- Being tested
- Intravascular Near Infrared Spectroscopy
- Keywords
- near infrared spectroscopy, LipiScan, lipid core, percutaneous coronary intervention, myocardial infarction, NIRS, intravascular imaging
- Medical subject headings
- Myocardial Infarction, Angina Pectoris, Coronary Artery Disease, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravascular Near Infrared SpectroscopyDevice
Also called LipiScan Coronary Imaging System
Intravascular imaging with a catheter based spectroscopy system.
| Study group | Role | What they receive |
|---|---|---|
| LipiScan | Subjects who have at least one native coronary artery imaged with the LipiScan CIS. Receives: Device: Intravascular Near Infrared Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify associations of LCP with angiographic or symptomatic presentation of coronary artery disease in a catheterization laboratory population
Measured: after completion of the study - during data analysis
Secondary outcomes (1)
Identification of associations that LCP or the Lipid Core Burden Index (LCBI) may have with atherosclerosis appearance, progression, regression, and/or cardiac event
Measured: Upto 2 years post procedure(baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionFeb 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,067 participants (actual)
Sponsor and investigators
- Lead sponsor
- Infraredx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giora Weisz, MD, Study chair, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00831116
- Sponsor's protocol ID
- 0111
- Acronym
- COLOR
- Status last verified
- Jun 2017
- First submitted
- 27 Jan 2009
- Last updated
- 9 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chemometric Observation of Lipid Core Plaques of Interest in Native Coronary Arteries Registry
- ClinicalTrials.gov ID
- NCT00831116
- Acronym / sponsor ID
- COLOR / 0111
- Keywords
- near infrared spectroscopy, LipiScan, lipid core, percutaneous coronary intervention, myocardial infarction, NIRS, intravascular imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,067 participants (actual)
- Lead sponsor
- InfraredxIndustry (pharma, biotech, devices)
- Study start
- Feb 2009 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 28 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LipiScan | – | Device: Intravascular Near Infrared SpectroscopySubjects who have at least one native coronary artery imaged with the LipiScan CIS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from those presenting or referred to the cardiac catheterization laboratory for elective cardiac catheterization.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravascular Near Infrared SpectroscopyAlso: LipiScan Coronary Imaging SystemIntravascular imaging with a catheter based spectroscopy system. | Device | LipiScan |
Primary outcome
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
1 secondary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giora Weisz, MD study chair
Columbia University
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and Angina, run by Infraredx at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2017.