SPECTACL: SPECTroscopic Assessment of Coronary Lipid (SPECTACL)

Tracking Information
First Submitted Date ICMJE	May 26, 2006
First Posted Date ICMJE	May 29, 2006
Results First Submitted Date	January 28, 2009
Results First Posted Date	May 28, 2009
Last Update Posted Date	October 10, 2016
Study Start Date ICMJE	January 2006
Actual Primary Completion Date	October 2007 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: August 29, 2016)	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.
Original Primary Outcome Measures ICMJE; (submitted: May 26, 2006)	Similarity of spectra obtained within the coronary arteries of patients at baseline and spectra obtained from coronary artery autopsy specimens.
Change History	Complete list of historical versions of study NCT00330928 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: August 29, 2016)	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.; 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 ]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 ]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.
Original Secondary Outcome Measures ICMJE; (submitted: May 26, 2006)	Review of lipid-rich plaque NIR signals observed at baseline in patients with stable angina vs ACS; Identification of distinct NIR spectral characteristics associated with special coronary artery features identified by angiography and/or IVUS and patient characteristics; Clinical Cardiac Events that occur during followup at 1yr.
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	SPECTACL: SPECTroscopic Assessment of Coronary Lipid
Official Title ICMJE	Coronary Artery Plaque Characterization by NIR Spectroscopy in Patients Undergoing Elective Percutaneous Coronary Intervention
Brief 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).
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 ICMJE	Interventional
Study Phase	Phase 2; Phase 3
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
Condition ICMJE	Angina Pectoris; Angina, Unstable; Myocardial Infarction
Intervention ICMJE	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. Other Names: Volcano, Revolution Volcano, Eagle Eye Boston Scientific, Atlantis
Study Arms	Experimental: 1; Subjects undergoing elective percutaneous coronary intervention; Interventions: Device: Near Infrared Spectroscopy (NIRS) Imaging; Device: intravascular ultrasound (IVUS)
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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: April 6, 2009)	106
Original Enrollment ICMJE; (submitted: May 26, 2006)	110
Actual Study Completion Date	October 2008
Actual Primary Completion Date	October 2007 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Canada, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00330928
Other Study ID Numbers ICMJE	0101; CL0101
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Director of Clinical & Regulatory Affairs, InfraReDx Inc.
Study Sponsor ICMJE	InfraReDx
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Sergio Waxman, MD Lahey Clinic, Burlington, MA, USA
PRS Account	InfraReDx
Verification Date	August 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP