Coronary Artery DiseaseLUNARNCT01747525
Near-Infrared Spectroscopy and Ultrasound Investigation of Coronary Artery Plaque
An observational study of Coronary Artery Disease and Atherosclerosis, run by Corewell Health East at 1 site in United States.
Trial summary
The primary objective of this study is to characterize coronary artery blockages as determined by the LipiScan combined NIRS-IVUS catheter using multi-vessel imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Atherosclerosis
- What is being tested?
- NIRS/IVUS of coronary artery
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Oct 2013
- 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: All patients presenting to Beaumont Hospital for elective invasive coronary angioplasty and possible percutaneous intervention.
Who may be able to join
- Subject is at least 18 years of age;
- Subject is scheduled for elective, clinically-indicated, invasive coronary angiography;
- Subject is willing and able to provide informed written consent prior to invasive angiography;
- Combined NIRS-IVUS is not contra-indicated per the cardiologist performing invasive coronary angiography; and
- Patient has either: (a) An epicardial coronary artery stenosis of intermediate severity (>50% to <70% stenosis)by invasive angiography in whom IVUS is planned to further evaluate lesion severity; or (b) A severe epicardial coronary artery stenosis by invasive angiography and percutaneous coronary intervention (PCI) is planned for definitive treatment.
Who cannot join
- Subject life expectancy at time of invasive angiography is less than 2 years;
- Subject is pregnant or suspected to be pregnant;
- Subject is unable to provide informed consent;
- Any factor deemed by the treating cardiologist to put the patient at increased risk of participating in the protocol (i.e. coronary artery anatomy is not suitable for traditional IVUS secondary to severe tortuousity or excessive calcification).
- Bacteremia or sepsis,
- Major coagulation system abnormalities,
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- Severe hemodynamic instability or shock,
- Patients diagnosed with coronary artery spasm,
- Patients disqualified for CABG surgery,
- Total occlusion,
- Patients disqualified for PTCA,
- Patients who are not suitable for IVUS procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lipiscan and Ultrasound Interrogation of Atherosclerotic Coronary Arteries (LUNAR)
The primary objective of this study is to characterize coronary artery blockages as determined by the LipiScan combined NIRS-IVUS catheter using multi-vessel imaging.
Read the detailed description
This is a prospective, observational, single-center registry that will enroll 100 patients. All patients presenting to Beaumont Hospital for elective invasive coronary angiography and possible ad hoc percutaneous coronary intervention balloon angioplasty will be considered for inclusion. Patients must meet all inclusion and exclusion criteria prior to consent. All information requested as part of this study will be obtained from clinical data as part of each subject's standard medical care. Cardiac catheterization and percutaneous coronary intervention will be performed according to standard guidelines and clinical practice. All aspects of clinical care of the patient will follow routine standards as determined by institutional policies, published clinical practice guidelines, and the treating physician.
After completion of routine invasive coronary angiography and upon determining that the patient has either (1) an epicardial de novo coronary artery lesion of indeterminate severity (>50% to <70% stenosis) that requires IVUS analysis for further delineation of stenosis (blockage) severity; or (2) a severe epicardial de novo coronary artery lesion that requires PCI for definitive treatment, combined NIR-IVUS imaging will be carried out in the target-vessel. Upon completion of NIRS-IVUS imaging of the target-vessel, percutaneous intervention will be performed in the standard fashion if deemed clinically appropriate. Upon completion of target-vessel intervention, NIRS-IVUS imaging will then be repeated in the target-vessel.
Upon completion of the treatment of the target-vessel, NIRS-IVUS will be performed in any other major epicardial vessel containing a stenosis ≥30% if deemed appropriate by the treating cardiologist.
Patients will be carefully monitored throughout their hospital stay and will be followed either by office visit or by telephone at 6 months (± 7 days); 12 months (± 14 days); 24 months (± 30 days); 36 months (± 30 days); 48 months (± 30 days); and 60 months (± 30 days).
The patient's medical records will be accessed to collect data about medical history and activities during the course of the study. All data will be collected by using standard case report forms. Follow up data after discharge will be collected using a phone script questionnaire . All data forms will include unique study identifiers to protect the participants personal identity. All data will be recorded in an Excel spreadsheet and kept on a secure computer requiring password entry.
There are no additional required medical procedures as part of this protocol beyond the use of the NIRS-IVUS catheter during the index procedure.
- Conditions
- Coronary Artery Disease, Atherosclerosis
- Being tested
- NIRS/IVUS of coronary artery
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRS/IVUS of coronary arteryDevice
Also called Infraredx
Evaluation of coronary plaque by NIRS/IVUS.
| Study group | Role | What they receive |
|---|---|---|
| NIRS/IVUS of coronary artery | All patients will have an epicardial coronary artery stenosis of intermediate severity (>50% to <70% stenosis) (stenosis ≥20% - ≤70%) by invasive angiography in whom IVUS is planned to further clinical evaluation of lesion severity; or a severe epicardial coronary artery stenosis by invasive angiography and percutaneous coronary intervention (PCI) is planned for definitive treatment. Receives: Device: NIRS/IVUS of coronary artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Near-Infrared Spectroscopy and Ultrasound Investigation of Coronary Artery Plaque
The primary objective of this study is to characterize coronary artery blockages as determined by the Lipiscan combined NIRS-IVUS catheter in multiple coronary arteries.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2012 (estimated)
- Study startOct 2011
- Primary completionOct 2013
- Study completionOct 2013
Why it stopped: It was decided not to proceed with the study at this time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Dixon, MD, Corewell Health East
- Investigators
- Simon R Dixon, MBChB, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01747525
- Sponsor's protocol ID
- 2011-258
- Acronym
- LUNAR
- Status last verified
- Jan 2018
- First submitted
- 7 Dec 2012
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipiscan and Ultrasound Interrogation of Atherosclerotic Coronary Arteries (LUNAR)
- ClinicalTrials.gov ID
- NCT01747525
- Acronym / sponsor ID
- LUNAR / 2011-258
- Conditions
- Coronary Artery Disease, Atherosclerosis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: It was decided not to proceed with the study at this time.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- Oct 2011 (actual)
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 11 Dec 2012 (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.
The primary objective of this study is to characterize coronary artery blockages as determined by the LipiScan combined NIRS-IVUS catheter using multi-vessel imaging.
Detailed description
This is a prospective, observational, single-center registry that will enroll 100 patients. All patients presenting to Beaumont Hospital for elective invasive coronary angiography and possible ad hoc percutaneous coronary intervention balloon angioplasty will be considered for inclusion. Patients must meet all inclusion and exclusion criteria prior to consent. All information requested as part of this study will be obtained from clinical data as part of each subject's standard medical care. Cardiac catheterization and percutaneous coronary intervention will be performed according to standard guidelines and clinical practice. All aspects of clinical care of the patient will follow routine standards as determined by institutional policies, published clinical practice guidelines, and the treating physician.
After completion of routine invasive coronary angiography and upon determining that the patient has either (1) an epicardial de novo coronary artery lesion of indeterminate severity (>50% to <70% stenosis) that requires IVUS analysis for further delineation of stenosis (blockage) severity; or (2) a severe epicardial de novo coronary artery lesion that requires PCI for definitive treatment, combined NIR-IVUS imaging will be carried out in the target-vessel. Upon completion of NIRS-IVUS imaging of the target-vessel, percutaneous intervention will be performed in the standard fashion if deemed clinically appropriate. Upon completion of target-vessel intervention, NIRS-IVUS imaging will then be repeated in the target-vessel.
Upon completion of the treatment of the target-vessel, NIRS-IVUS will be performed in any other major epicardial vessel containing a stenosis ≥30% if deemed appropriate by the treating cardiologist.
Patients will be carefully monitored throughout their hospital stay and will be followed either by office visit or by telephone at 6 months (± 7 days); 12 months (± 14 days); 24 months (± 30 days); 36 months (± 30 days); 48 months (± 30 days); and 60 months (± 30 days).
The patient's medical records will be accessed to collect data about medical history and activities during the course of the study. All data will be collected by using standard case report forms. Follow up data after discharge will be collected using a phone script questionnaire . All data forms will include unique study identifiers to protect the participants personal identity. All data will be recorded in an Excel spreadsheet and kept on a secure computer requiring password entry.
There are no additional required medical procedures as part of this protocol beyond the use of the NIRS-IVUS catheter during the index procedure.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NIRS/IVUS of coronary artery | – | Device: NIRS/IVUS of coronary arteryAll patients will have an epicardial coronary artery stenosis of intermediate severity (>50% to <70% stenosis) (stenosis ≥20% - ≤70%) by invasive angiography in whom IVUS is planned to further clinical evaluation of lesion severity; or a severe epicardial coronary artery stenosis by invasive angiography and percutaneous coronary intervention (PCI) is planned for definitive treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients presenting to Beaumont Hospital for elective invasive coronary angioplasty and possible percutaneous intervention.
Key inclusion criteria (5 listed)
- Subject is at least 18 years of age;
- Subject is scheduled for elective, clinically-indicated, invasive coronary angiography;
- Subject is willing and able to provide informed written consent prior to invasive angiography;
- Combined NIRS-IVUS is not contra-indicated per the cardiologist performing invasive coronary angiography; and
- Patient has either: (a) An epicardial coronary artery stenosis of intermediate severity (>50% to <70% stenosis)by invasive angiography in whom IVUS is planned to further evaluate lesion severity; or (b) A severe epicardial coronary artery stenosis by invasive angiography and percutaneous coronary intervention (PCI) is planned for definitive treatment.
Key exclusion criteria (12 listed)
- Subject life expectancy at time of invasive angiography is less than 2 years;
- Subject is pregnant or suspected to be pregnant;
- Subject is unable to provide informed consent;
- Any factor deemed by the treating cardiologist to put the patient at increased risk of participating in the protocol (i.e. coronary artery anatomy is not suitable for traditional IVUS secondary to severe tortuousity or excessive calcification).
- Bacteremia or sepsis,
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 |
|---|---|---|
| NIRS/IVUS of coronary arteryAlso: InfraredxEvaluation of coronary plaque by NIRS/IVUS. | Device | NIRS/IVUS of coronary artery |
Primary outcome
Near-Infrared Spectroscopy and Ultrasound Investigation of Coronary Artery Plaque
Time frame: 1 year
The primary objective of this study is to characterize coronary artery blockages as determined by the Lipiscan combined NIRS-IVUS catheter in multiple coronary arteries.
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 9 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
Simon R Dixon, MBChB principal investigator
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Atherosclerosis, run by Corewell Health East at 1 site 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 12 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 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Near-Infrared Spectroscopy and Ultrasound Investigation of Coronary Artery Plaque (time frame: 1 year). 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 Jan 2018.