- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00330928
SPECTACL: SPECTroscopic Assessment of Coronary Lipid (SPECTACL)
Coronary Artery Plaque Characterization by NIR Spectroscopy in Patients Undergoing Elective Percutaneous Coronary Intervention
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H1T 1C8
- Montreal Heart Institute
-
-
-
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Massachusetts
-
Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Medical Center
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Burlington, Massachusetts, United States, 01805
- Lahey Clinic
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Michigan
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Royal Oak, Michigan, United States, 48073
- William Beaumont Hospital
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
-
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North Carolina
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Durham, North Carolina, United States, 27705
- Duke Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- >=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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Subjects undergoing elective percutaneous coronary intervention
|
Near infrared spectroscopic imaging of the coronary artery with an intravascular spectroscopy catheter.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
Baseline
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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
|
Baseline
|
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Clinical Cardiac Events Definitely Attributable to the Study Device That Occur From Enrollment to 7 Days Post Enrollment
Time Frame: Baseline to 7 day
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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.
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Baseline to 7 day
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Cardiac Events That Occur Within 1 Year Post Enrollment Will be Examined for Link to Lipid Signals.
Time Frame: 1 year
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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.
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sergio Waxman, MD, Lahey Clinic, Burlington, MA, USA
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0101
- CL0101
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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