Coronary Artery DiseasePhase 4NCT01506960
Evaluation of a Combined Near Infrared Spectroscopy (NIRS) and Intravascular Ultrasound (IVUS) Catheter for Detection of Lipid Rich Plaque
A Phase 4 study testing InfraReDx Lipiscan IVUS in people with Coronary Artery Disease, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to learn more about lipid rich plaque using Near Infrared Spectroscopy (NIRS)/Intravascular Ultrasound (IVUS) imaging in patients who have had coronary artery stenting and Optical coherence tomography (OCT) imaging. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- InfraReDx Lipiscan IVUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jun 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient Characteristics
- Males and non-pregnant females > 18 and < 79 years of age
- Patients referred for diagnostic coronary angiography who are found to have lesions in native coronary arteries which will be treated by percutaneous coronary intervention (PCI) (or patients with known coronary lesions who are referred for planned PCI)
- Able to give written informed consent
- Lesion Characteristics
- Lesion in native coronary artery
Show all 25Show fewer
- Angiographic stenosis > 50%
- Reference vessel diameter 2.5 mm - 4.0 mm by visual estimation
- Subjects who have successful PCI and OCT
- General Exclusion Criteria
- Subjects who are unable or unwilling to sign the informed consent form
- Subjects with serious co-morbid conditions that in judgment of the investigator preclude inclusion in this study (such as terminal cancer, life expectancy < 6 months, Liver Function Tests (LFTs) > 3 times Upper Limit of Normal (ULN), or post-transplant)
- Subjects with New York Heart Association (NYHA) class III or IV heart failure or known left ventricular ejection fraction < 30%
- Subjects who have experienced an ST-elevation myocardial infarction (STEMI) within 72 hours prior to the procedure
- Subjects with hemodynamic or electrical instability (including shock)
- Subjects diagnosed with severe, non-catheter-related coronary artery spasm
- Subjects who are or may be pregnant
- Subjects with known allergies to contrast media
- Subjects with renal failure as defined by estimated Glomerular Filtration Rate (eGFR) < 60.
- History of Transient Ischemic Attack (TIA) or stroke < 6 months
- Lesion Specific Exclusion Criteria These exclusion criteria apply to the target lesion to be imaged by NIRS IVUS.
- Lesion located in the left main coronary artery
- Lesions that are heavily calcified
- Lesions where OCT cannot be performed due to technical difficulties
- Other lesions that the investigator deems inappropriate for the procedure such as lesions with excessive tortuosity, presence of thrombus, low flow by TIMI grade.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The purpose of this study is to learn more about lipid rich plaque using Near Infrared Spectroscopy (NIRS)/Intravascular Ultrasound (IVUS) imaging in patients who have had coronary artery stenting and Optical coherence tomography (OCT) imaging.
Read the detailed description
The aims of this study are to:
- Test the ability of the new NIRS IVUS system to detect lipid pool
- Evaluate the accuracy of the NIRS IVUS system for localization of lipide rich plaque: superficial vs deep
- Improve diagnostic accuracy of OCT for detection of lipid using information from NIRS IVUS
- Conditions
- Coronary Artery Disease
- Being tested
- InfraReDx Lipiscan IVUS
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfraReDx Lipiscan IVUSDevice
Near Infrared Spectroscopy/Intravascular Ultrasound will be performed following OCT imaging.
| Study group | Role | What they receive |
|---|---|---|
| Coronary stenting with OCT, NIRS/IVUS | Experimental | All subjects will have Near Infrared Spectroscopy/Intravascular Ultrasound Imaging performed. Receives: Device: InfraReDx Lipiscan IVUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Lipid Rich Plaque by Near Infrared Spectroscopy (NIRS) Intravascular Ultrasound (IVUS)
Subjects are presenting for their clinically-indicated cardiac catheterization. NIRS/IVUS imaging will be done at the time of catheterization.
Measured: Measured one point in time during cardiac catheterization
Secondary outcomes (1)
Differences in NIRS Parameters Between Deep and Superficial Lipid Assessed by Optical Coherence Tomography (OCT).
Subjects are presenting for their clinically-indicated cardiac catheterization. NIRS/IVUS imaging will be done at the time of catheterization. Plaques were divided depending on depth of lipid by OCT (cut off value 130 um).
Measured: Measured at the time of cardiac catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2012
- Study completionJun 2012
Why it stopped: It was felt that a sufficient number of subjects were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Infraredx
- Responsible party
- Principal investigator, Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital
- Investigators
- Ik-Kyung Jang, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506960
- Sponsor's protocol ID
- 2010P001608
- Status last verified
- Oct 2013
- First submitted
- 3 Jan 2012
- Last updated
- 18 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Combined Near Infrared Spectroscopy (NIRS) and Intravascular Ultrasound (IVUS) Catheter for Detection of Lipid Rich Plaque
- ClinicalTrials.gov ID
- NCT01506960
- Acronym / sponsor ID
- 2010P001608
- Conditions
- Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It was felt that a sufficient number of subjects were enrolled.
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Infraredx
- Study start
- Jan 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 10 Jan 2012 (estimated)
- Results
- Posted 18 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn more about lipid rich plaque using Near Infrared Spectroscopy (NIRS)/Intravascular Ultrasound (IVUS) imaging in patients who have had coronary artery stenting and Optical coherence tomography (OCT) imaging.
Detailed description
The aims of this study are to:
- Test the ability of the new NIRS IVUS system to detect lipid pool
- Evaluate the accuracy of the NIRS IVUS system for localization of lipide rich plaque: superficial vs deep
- Improve diagnostic accuracy of OCT for detection of lipid using information from NIRS IVUS
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary stenting with OCT, NIRS/IVUS | Experimental | Device: InfraReDx Lipiscan IVUSAll subjects will have Near Infrared Spectroscopy/Intravascular Ultrasound Imaging performed. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Patient Characteristics
- Males and non-pregnant females > 18 and < 79 years of age
- Patients referred for diagnostic coronary angiography who are found to have lesions in native coronary arteries which will be treated by percutaneous coronary intervention (PCI) (or patients with known coronary lesions who are referred for planned PCI)
- Able to give written informed consent
- Lesion Characteristics
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| InfraReDx Lipiscan IVUSNear Infrared Spectroscopy/Intravascular Ultrasound will be performed following OCT imaging. | Device | Coronary stenting with OCT, NIRS/IVUS |
Primary outcome
Detection of Lipid Rich Plaque by Near Infrared Spectroscopy (NIRS) Intravascular Ultrasound (IVUS)
Time frame: Measured one point in time during cardiac catheterization
Subjects are presenting for their clinically-indicated cardiac catheterization. NIRS/IVUS imaging will be done at the time of catheterization.
1 secondary outcome
Differences in NIRS Parameters Between Deep and Superficial Lipid Assessed by Optical Coherence Tomography (OCT).
Time frame: Measured at the time of cardiac catheterization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ik-Kyung Jang, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing InfraReDx Lipiscan IVUS in people with Coronary Artery Disease, run by Massachusetts General Hospital 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 25 inclusion and 0 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: stopped early, as of the sponsor's last update on 18 Nov 2013. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Detection of Lipid Rich Plaque by Near Infrared Spectroscopy (NIRS) Intravascular Ultrasound (IVUS) (time frame: Measured one point in time during cardiac catheterization). 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 18 Nov 2013.