Clinical trial NCT00330928: SPECTACL: SPECTroscopic Assessment of Coronary Lipid
Official title: Coronary Artery Plaque Characterization by NIR Spectroscopy in Patients Undergoing Elective Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Angina Pectoris
Angina, Unstable
Myocardial Infarction
Lead sponsor: Infraredx
Sponsor class: INDUSTRY
First posted: 2006-05-29
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Spectral Similarity
timeFrame: Baseline
Secondary outcomes:
measure: Review of Lipid Core Plaque of Interest Near Infrared Signals Observed at Baseline in Patients With Stable Angina vs Acute Coronary Syndromes
timeFrame: Baseline
measure: Identification of Distinct Near Infrared Spectral Characteristics Associated With Special Coronary Artery Features Identified by Angiography and/or Intravascular Ultrasound and Patient Characteristics
timeFrame: Baseline
measure: Clinical Cardiac Events Definitely Attributable to the Study Device That Occur From Enrollment to 7 Days Post Enrollment
timeFrame: Baseline to 7 day
measure: Cardiac Events That Occur Within 1 Year Post Enrollment Will be Examined for Link to Lipid Signals.
timeFrame: 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Durham
country: United States
facility: Duke Medical Center
state: North Carolina
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
affiliation: Lahey Clinic, Burlington, MA, USA
name: Sergio Waxman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.