Coronary AtherosclerosisORACLE-NIRSNCT02265146
ORACLE-NIRS: Lipid cORe Plaque Association With CLinical Events: a Near-InfraRed Spectroscopy Study
An observational study of Coronary Atherosclerosis, run by University of Texas Southwestern Medical Center at 5 sites in United States.
Trial summary
This is a multi-center, investigator initiated study that will prospectively examine treatment strategies and outcomes of patients who underwent clinically-indicated Near Infrared Spectroscopy (NIRS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Atherosclerosis
- How many people
- 0 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2014to Dec 2030
- How long will I take part?
- 15 Years
- 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: Patients undergoing clinically-indicated Near Infrared Spectroscopy (NIRS) among various participating centers.
Who may be able to join
- 1. Patients who have undergone/ will be undergoing NIRS imaging at each of the participating centers.
Who cannot join
- None
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Atlanta VA Medical Center
Atlanta, Georgia
Jesse Brown VA Medical Center
Chicago, Illinois
VA North Texas Health Care System
Dallas, Texas
North Florida/(South Georgia) VA Health Care System
Gainesville, Florida
Minneapolis VA Medical Center
Minneapolis, Minnesota
About this study
Official title: Association of Lipid Core Plaque With Subsequent Clinical Outcomes: a Collaborative Near-infrared Spectroscopy Study
This is a multi-center, investigator initiated study that will prospectively examine treatment strategies and outcomes of patients who underwent clinically-indicated Near Infrared Spectroscopy (NIRS). The information collected will be used to determine the frequency of NIRS imaging performed at the participating sites and to examine the clinical outcomes of the NIRS-detected Lipid Core Plaques (LCPs).
- Conditions
- Coronary Atherosclerosis
- Keywords
- Lipid Core Plaques (LCPs), Vulnerable Plaque, Near Infrared Spectroscopy
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major adverse cardiac events
The primary endpoint for both hypotheses is the incidence of major adverse cardiac events. Major adverse cardiac events include the following:
- cardiac death
- cardiac arrest
- acute coronary syndrome
- stent thrombosis, repeat coronary angiography
- coronary revascularization (either by percutaneous coronary intervention or coronary artery bypass graft surgery).
- rehospitalization for progressive angina, attributed to a non-culprit lesion secondary to significant fixed, non-reversible (not-spasm related) lesion progression of more than 20% from the baseline study (confirmed by either serial angiography or by necropsy).
Events will be classified as events occurring at the site of stent implantation and events occurring at previously untreated lesions. Moreover, analyses will be performed on a per patient and per LCP basis.
Measured: 1 to 15 years following clinically indicated Near InfraRed Spectroscopy imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Why it stopped: 0
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary AtherosclerosisStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- 0 participants (actual)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanouil S Brilakis, MD, PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02265146
- Sponsor's protocol ID
- STU 112013-073
- Acronym
- ORACLE-NIRS
- Status last verified
- Oct 2023
- First submitted
- 26 Sep 2014
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Lipid Core Plaque With Subsequent Clinical Outcomes: a Collaborative Near-infrared Spectroscopy Study
- ClinicalTrials.gov ID
- NCT02265146
- Acronym / sponsor ID
- ORACLE-NIRS / STU 112013-073
- Conditions
- Coronary Atherosclerosis
- Keywords
- Lipid Core Plaques (LCPs), Vulnerable Plaque, Near Infrared Spectroscopy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: 0
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 15 Oct 2014 (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.
This is a multi-center, investigator initiated study that will prospectively examine treatment strategies and outcomes of patients who underwent clinically-indicated Near Infrared Spectroscopy (NIRS). The information collected will be used to determine the frequency of NIRS imaging performed at the participating sites and to examine the clinical outcomes of the NIRS-detected Lipid Core Plaques (LCPs).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing clinically-indicated Near Infrared Spectroscopy (NIRS) among various participating centers.
Key inclusion criteria (1 listed)
- 1. Patients who have undergone/ will be undergoing NIRS imaging at each of the participating centers.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of major adverse cardiac events
Time frame: 1 to 15 years following clinically indicated Near InfraRed Spectroscopy imaging
The primary endpoint for both hypotheses is the incidence of major adverse cardiac events. Major adverse cardiac events include the following: * cardiac death * cardiac arrest * acute coronary syndrome * stent thrombosis, repeat coronary angiography * coronary revascularization (either by percutaneous coronary intervention or coronary artery bypass graft surgery). * rehospitalization for progressive angina, attributed to a non-culprit lesion secondary to significant fixed, non-reversible (not-spasm related) lesion progression of more than 20% from the baseline study (confirmed by either serial angiography or by necropsy). Events will be classified as events occurring at the site of stent implantation and events occurring at previously untreated lesions. Moreover, analyses will be performed on a per patient and per LCP basis.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
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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.
Emmanouil S Brilakis, MD, PhD principal investigator
University of Texas Southwestern Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Atherosclerosis, run by University of Texas Southwestern Medical Center at 5 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 was withdrawn before enrolling participants, so there are no results.
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?
Incidence of major adverse cardiac events (time frame: 1 to 15 years following clinically indicated Near InfraRed Spectroscopy imaging). 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 23 Oct 2023.