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SPECTACL: SPECTroscopic Assessment of Coronary Lipid

This study has been completed.
Sponsor:
Information provided by:
InfraReDx
ClinicalTrials.gov Identifier:
NCT00330928
First received: May 26, 2006
Last updated: July 14, 2009
Last verified: July 2009
History of Changes
  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 2
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Angina Heart Attack
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
Experimental: 1
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.
Other Names:
  • Volcano, Revolution
  • Volcano, Eagle Eye
  • Boston Scientific, Atlantis

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
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Lahey Clinic
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
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 ClinicalTrials.gov Identifier (NCT Number):

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

Additional relevant MeSH terms:
Angina Pectoris
Angina, Unstable
Infarction
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
 Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on May 22, 2013