Angina PectorisPhase 2/3SPECTACLNCT00330928
SPECTACL: SPECTroscopic Assessment of Coronary Lipid
A Phase 2/3 study testing Near Infrared Spectroscopy (NIRS) Imaging and intravascular ultrasound (IVUS) in people with Angina Pectoris and Angina, Unstable, run by Infraredx at 6 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate a near-infrared (NIR) spectroscopy system that has been designed to identify the chemical composition of coronary artery plaques in patients undergoing a percutaneous coronary intervention (PCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angina Pectoris, Angina, Unstable, Myocardial Infarction
- What is being tested?
- Near Infrared Spectroscopy (NIRS) Imaging and intravascular ultrasound (IVUS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Jan 2006to Oct 2008
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >=18yrs and undergoing elective or non-emergent PCI of a de novo native coronary artery lesion
- Treatment plan (at time of consent and at time of intervention) must be to perform an intervention on no more than 2 lesions, where one is the culprit lesion and the other lesion requires revascularization at the discretion of the treating physician.
- Target lesion should have "low-risk" characteristics(defined by angiography)
- Subject must be able to read, understand and sign an approved informed consent form and follow protocol
- Female subjects of child bearing potential must have a negative serum pregnancy test prior to enrollment
Who cannot join
- Evidence of Clinical instability in the 6 hours before the procedure, or at any time during the procedure (72 hours stable post-STEMI)
- Angiographically Unsuitable Coronary and/or Lesion Morphology in the culprit vessel.
- A contraindication to anticoagulation or increased risk of bleeding.
- Clinically significant abnormal laboratory findings
- Presence of a drug eluting stent in the artery for experimental study prior to NIR measurement, unless all struts are covered by endothelium as documented by IVUS
- Elective PCI on or through bypass grafts or LIMA grafts
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- Allergy or intolerance to aspirin or clopidogrel
- Planned use of laser ablation, rotational ablation, brachytherapy, or atherectomy device
- Enrollment or participation in any other medication trial within the previous 30 days
- Current enrollment participation or enrolled in another clinical trial
- Any other factor that the investigator feels would put the patient at increased risk if participating in the protocol
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Lahey Clinic
Burlington, Massachusetts, 01805
Duke Medical Center
Durham, North Carolina, 27705
Columbia University Medical Center
New York, New York, 10032
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Official title: Coronary Artery Plaque Characterization by NIR Spectroscopy in Patients Undergoing Elective Percutaneous Coronary Intervention
The purpose of this study is to evaluate a near-infrared (NIR) spectroscopy system that has been designed to identify the chemical composition of coronary artery plaques in patients undergoing a percutaneous coronary intervention (PCI).
Read the detailed description
Extensive studies conducted over the past 7 years in autopsy specimens have demonstrated that NIR spectroscopy can identify the plaque structures that are suspected to cause the acute coronary artery syndromes(unstable angina, myocardial infarction, and sudden death).
The application of NIR spectroscopy to identify lipid deposition within coronary arteries has shown promising results in preclinical ex vivo studies (14). Infrared spectra are collected as follows: light of discrete wavelengths from a laser is directed onto the tissue sample via glass fibers. Light scattered from the samples is collected in fibers and launched into a spectrometer. The plot of signal intensity as a function of wavelength can be then used to develop chemometric models to discriminate lipid-rich deposits from non-atherosclerotic tissue, and from atherosclerotic tissue that is predominantly fibrotic and from blood elements. This technique is incorporated into a thin catheter with similar dimensions to an IVUS catheter, and the intracoronary dwell time for analysis is similar to the broad experience with established techniques with proven safety, such as IVUS.
- Conditions
- Angina Pectoris, Angina, Unstable, Myocardial Infarction
- Being tested
- Near Infrared Spectroscopy (NIRS) Imaging, intravascular ultrasound (IVUS)
- Medical subject headings
- Angina Pectoris, Angina, Unstable, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near Infrared Spectroscopy (NIRS) ImagingDevice
Also called InfraReDx, LipiScan (prototype)
Near infrared spectroscopic imaging of the coronary artery with an intravascular spectroscopy catheter.
intravascular ultrasound (IVUS)Device
Also called Volcano, Revolution, Volcano, Eagle Eye, Boston Scientific, Atlantis
Ultrasound coronary catheter is positioned on a guidewire that has been placed in the coronary artery.Ultrasound imaging provides structural information about the vessel wall and blockages contained. It takes approximately 5 minutes to prepare, position, and to collect data with the catheter.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Subjects undergoing elective percutaneous coronary intervention Receives: Device: Near Infrared Spectroscopy (NIRS) Imaging; Device: intravascular ultrasound (IVUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spectral Similarity
Average spectral similarity of the spectra in a complete scan per patient as compared to the autopsy spectral data set.Clinical data was considered similar to autopsy data if average spectral similarity in each scan was >=67%, on a continuous range of 0%(different) to 100%(identical) similarity.
Measured: Baseline
Secondary outcomes (4)
Review of Lipid Core Plaque of Interest Near Infrared Signals Observed at Baseline in Patients With Stable Angina vs Acute Coronary Syndromes
This is an exploratory examination to determine if an association exists between the presence or characteristics of lipid core plaques of interest signals and the clinical designation of acute or stable coronary artery disease in enrolled subjects. The study is not powered for statistical significance for this outcome.
Measured: Baseline
Identification of Distinct Near Infrared Spectral Characteristics Associated With Special Coronary Artery Features Identified by Angiography and/or Intravascular Ultrasound and Patient Characteristics
Measured: Baseline
Clinical Cardiac Events Definitely Attributable to the Study Device That Occur From Enrollment to 7 Days Post Enrollment
Major adverse cardiac events (MACE: myocardial infarction, cardiac surgery, death, cerebral vascular accident, coronary revascularization) will be evaluated for being categorized as Definitely attributable to the study device.
Measured: Baseline to 7 day
Cardiac Events That Occur Within 1 Year Post Enrollment Will be Examined for Link to Lipid Signals.
Major adverse cardiac events (MACE: myocardial infarction, cardiac surgery, death, cerebral vascular accident, coronary revascularization) will be evaluated relation to baseline presence of lipid signals by near infrared spectroscopy. This study is not powered to reach statistical significance for this outcome.
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 posted29 May 2006 (estimated)
- Study startJan 2006
- Primary completionOct 2007
- Study completionOct 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Angina PectorisStudies 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Infraredx
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Sergio Waxman, MD, Principal investigator, Lahey Clinic, Burlington, MA, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00330928
- Sponsor's protocol ID
- 0101
- Other IDs
- CL0101
- Acronym
- SPECTACL
- Status last verified
- Dec 2020
- First submitted
- 26 May 2006
- Last updated
- 5 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Waxman S, Dixon SR, L'Allier P, Moses JW, Petersen JL, Cutlip D, Tardif JC, Nesto RW, Muller JE, Hendricks MJ, Sum ST, Gardner CM, Goldstein JA, Stone GW, Krucoff MW. In vivo validation of a catheter-based near-infrared spectroscopy system for detection of lipid core coronary plaques: initial results of the SPECTACL study. JACC Cardiovasc Imaging. 2009 Jul;2(7):858-68. doi: 10.1016/j.jcmg.2009.05.001.
PubMed 19608137
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Artery Plaque Characterization by NIR Spectroscopy in Patients Undergoing Elective Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT00330928
- Acronym / sponsor ID
- SPECTACL / 0101
- Conditions
- Angina Pectoris, Angina, Unstable, Myocardial Infarction
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- InfraredxIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 29 May 2006 (estimated)
- Results
- Posted 28 May 2009
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 evaluate a near-infrared (NIR) spectroscopy system that has been designed to identify the chemical composition of coronary artery plaques in patients undergoing a percutaneous coronary intervention (PCI).
Detailed description
Extensive studies conducted over the past 7 years in autopsy specimens have demonstrated that NIR spectroscopy can identify the plaque structures that are suspected to cause the acute coronary artery syndromes(unstable angina, myocardial infarction, and sudden death).
The application of NIR spectroscopy to identify lipid deposition within coronary arteries has shown promising results in preclinical ex vivo studies (14). Infrared spectra are collected as follows: light of discrete wavelengths from a laser is directed onto the tissue sample via glass fibers. Light scattered from the samples is collected in fibers and launched into a spectrometer. The plot of signal intensity as a function of wavelength can be then used to develop chemometric models to discriminate lipid-rich deposits from non-atherosclerotic tissue, and from atherosclerotic tissue that is predominantly fibrotic and from blood elements. This technique is incorporated into a thin catheter with similar dimensions to an IVUS catheter, and the intracoronary dwell time for analysis is similar to the broad experience with established techniques with proven safety, such as IVUS.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Near Infrared Spectroscopy (NIRS) Imaging, Device: intravascular ultrasound (IVUS)Subjects undergoing elective percutaneous coronary intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >=18yrs and undergoing elective or non-emergent PCI of a de novo native coronary artery lesion
- Treatment plan (at time of consent and at time of intervention) must be to perform an intervention on no more than 2 lesions, where one is the culprit lesion and the other lesion requires revascularization at the discretion of the treating physician.
- Target lesion should have "low-risk" characteristics(defined by angiography)
- Subject must be able to read, understand and sign an approved informed consent form and follow protocol
- Female subjects of child bearing potential must have a negative serum pregnancy test prior to enrollment
Key exclusion criteria (11 listed)
- Evidence of Clinical instability in the 6 hours before the procedure, or at any time during the procedure (72 hours stable post-STEMI)
- Angiographically Unsuitable Coronary and/or Lesion Morphology in the culprit vessel.
- A contraindication to anticoagulation or increased risk of bleeding.
- Clinically significant abnormal laboratory findings
- Presence of a drug eluting stent in the artery for experimental study prior to NIR measurement, unless all struts are covered by endothelium as documented by IVUS
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 |
|---|---|---|
| Near Infrared Spectroscopy (NIRS) ImagingAlso: InfraReDx, LipiScan (prototype)Near infrared spectroscopic imaging of the coronary artery with an intravascular spectroscopy catheter. | Device | 1 |
| intravascular ultrasound (IVUS)Also: Volcano, Revolution, Volcano, Eagle Eye, Boston Scientific, AtlantisUltrasound coronary catheter is positioned on a guidewire that has been placed in the coronary artery.Ultrasound imaging provides structural information about the vessel wall and blockages contained. It takes approximately 5 minutes to prepare, position, and to collect data with the catheter. | Device | 1 |
Primary outcome
Spectral Similarity
Time frame: Baseline
Average spectral similarity of the spectra in a complete scan per patient as compared to the autopsy spectral data set.Clinical data was considered similar to autopsy data if average spectral similarity in each scan was >=67%, on a continuous range of 0%(different) to 100%(identical) similarity.
4 secondary outcomes
Review of Lipid Core Plaque of Interest Near Infrared Signals Observed at Baseline in Patients With Stable Angina vs Acute Coronary Syndromes
Time frame: Baseline
Identification of Distinct Near Infrared Spectral Characteristics Associated With Special Coronary Artery Features Identified by Angiography and/or Intravascular Ultrasound and Patient Characteristics
Time frame: Baseline
Clinical Cardiac Events Definitely Attributable to the Study Device That Occur From Enrollment to 7 Days Post Enrollment
Time frame: Baseline to 7 day
Cardiac Events That Occur Within 1 Year Post Enrollment Will be Examined for Link to Lipid Signals.
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19608137Waxman S, Dixon SR, L'Allier P, Moses JW, Petersen JL, Cutlip D, Tardif JC, Nesto RW, Muller JE, Hendricks MJ, Sum ST, Gardner CM, Goldstein JA, Stone GW, Krucoff MW. In vivo validation of a catheter-based near-infrared spectroscopy system for detection of lipid core coronary plaques: initial results of the SPECTACL study. JACC Cardiovasc Imaging. 2009 Jul;2(7):858-68. doi: 10.1016/j.jcmg.2009.05.001.
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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.
Sergio Waxman, MD principal investigator
Lahey Clinic, Burlington, MA, USA
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Near Infrared Spectroscopy (NIRS) Imaging and intravascular ultrasound (IVUS) in people with Angina Pectoris and Angina, Unstable, run by Infraredx at 6 sites in 2 countries.
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 11 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 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 28 May 2009). 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?
Spectral Similarity (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00330928, which also lists 1 linked publication.
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 5 Jan 2021.