SPECTACL: SPECTroscopic Assessment of Coronary Lipid (SPECTACL)
Device: Near Infrared Spectroscopy (NIRS) Imaging
Device: intravascular ultrasound (IVUS)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Coronary Artery Plaque Characterization by NIR Spectroscopy in Patients Undergoing Elective Percutaneous Coronary Intervention|
- Spectral Similarity [ Time Frame: Baseline ] [ Designated as safety issue: No ]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.
- 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 ] [ Designated as safety issue: No ]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.
- 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 ] [ Designated as safety issue: No ]
- Clinical Cardiac Events Definitely Attributable to the Study Device That Occur From Enrollment to 7 Days Post Enrollment [ Time Frame: Baseline to 7 day ] [ Designated as safety issue: Yes ]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.
- Cardiac Events That Occur Within 1 Year Post Enrollment Will be Examined for Link to Lipid Signals. [ Time Frame: 1 year ] [ Designated as safety issue: No ]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.
|Study Start Date:||January 2006|
|Study Completion Date:||October 2008|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
Subjects undergoing elective percutaneous coronary intervention
Device: Near Infrared Spectroscopy (NIRS) Imaging
Near infrared spectroscopic imaging of the coronary artery with an intravascular spectroscopy catheter.
Other Name: InfraReDx, LipiScan (prototype)Device: intravascular ultrasound (IVUS)
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00330928
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Burlington, Massachusetts, United States, 01805|
|United States, Michigan|
|William Beaumont Hospital|
|Royal Oak, Michigan, United States, 48073|
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|United States, North Carolina|
|Duke Medical Center|
|Durham, North Carolina, United States, 27705|
|Montreal Heart Institute|
|Montreal, Quebec, Canada, H1T 1C8|
|Principal Investigator:||Sergio Waxman, MD||Lahey Clinic, Burlington, MA, USA|