SPECTACL: SPECTroscopic Assessment of Coronary Lipid - Full Text View

Sponsor:	InfraReDx
Information provided by:	InfraReDx
ClinicalTrials.gov Identifier:	NCT00330928

Purpose

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).

Condition	Intervention	Phase
Angina Pectoris Angina, Unstable Myocardial Infarction	Device: Near Infrared Spectroscopy (NIRS) Imaging Device: intravascular ultrasound (IVUS)	Phase II Phase III

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Coronary Artery Plaque Characterization by NIR Spectroscopy in Patients Undergoing Elective Percutaneous Coronary Intervention

Resource links provided by NLM:

MedlinePlus related topics: Angina Heart Attack Ultrasound

U.S. FDA Resources

Further study details as provided by InfraReDx:

Primary Outcome Measures:

Spectral Similarity [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]
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 ]
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 ]

Enrollment:	106
Study Start Date:	January 2006
Study Completion Date:	October 2008
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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. 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.

Arms

Assigned Interventions

1: Experimental

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.

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.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00330928

Locations

United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
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
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8

Sponsors and Collaborators

InfraReDx

Investigators

Principal Investigator:

Sergio Waxman, MD

Lahey Clinic, Burlington, MA, USA

More Information

Publications:

Waxman S, Simon R. Dixon, L'Allier P, Moses JW, Petersen JL, Cutlip D, Tardif J, 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 and Exploratory Analysis of the Spectroscopic Assessment of Coronary Lipid (SPECTACL) Multicenter Study. J Am Coll Cardiol Img. 2009; 2: 858-868.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	InfraReDx Inc. ( Director of Clinical & Regulatory Affairs )
Study ID Numbers:	0101, CL0101
Study First Received:	May 26, 2006
Results First Received:	January 28, 2009
Last Updated:	July 14, 2009
ClinicalTrials.gov Identifier:	NCT00330928 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Additional relevant MeSH terms:

Heart Diseases
Myocardial Ischemia
Angina Pectoris
Vascular Diseases
Pain
Ischemia
Chest Pain

Signs and Symptoms
Necrosis
Pathologic Processes
Cardiovascular Diseases
Infarction
Angina, Unstable
Myocardial Infarction

ClinicalTrials.gov processed this record on November 20, 2009