SPECTACL: SPECTroscopic Assessment of Coronary Lipid

Phase 2

Completed

Interventions: Device: Near Infrared Spectroscopy (NIRS) Imaging
Device: intravascular ultrasound (IVUS)

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
1	intravascular ultrasound (IVUS)	Subjects undergoing elective percutaneous coronary intervention
1	Near Infrared Spectroscopy (NIRS) Imaging	Subjects undergoing elective percutaneous coronary intervention

Primary Outcome Measures

Name	Time	Method
Spectral Similarity	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.

Secondary Outcome Measures

Name	Time	Method
Review of Lipid Core Plaque of Interest Near Infrared Signals Observed at Baseline in Patients With Stable Angina vs Acute Coronary Syndromes	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	Baseline
Clinical Cardiac Events Definitely Attributable to the Study Device That Occur From Enrollment to 7 Days Post Enrollment	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.	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.

Locations (6): Columbia University Medical Center
🇺🇸
New York, New York, United States
Duke Medical Center
🇺🇸
Durham, North Carolina, United States
Montreal Heart Institute
🇨🇦
Montreal, Quebec, Canada
Beth Israel Deaconess Medical Center
🇺🇸
Boston, Massachusetts, United States
Lahey Clinic
🇺🇸
Burlington, Massachusetts, United States
William Beaumont Hospital
🇺🇸
Royal Oak, Michigan, United States