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SPECTACL: SPECTroscopic Assessment of Coronary Lipid (SPECTACL)

This study has been completed.
Information provided by:
InfraReDx Identifier:
First received: May 26, 2006
Last updated: August 29, 2016
Last verified: August 2016
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
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

Further study details as provided by InfraReDx:

Primary Outcome Measures:
  • 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.

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 ]
    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.

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00330928

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
Principal Investigator: Sergio Waxman, MD Lahey Clinic, Burlington, MA, USA
  More Information

Responsible Party: Director of Clinical & Regulatory Affairs, InfraReDx Inc. Identifier: NCT00330928     History of Changes
Other Study ID Numbers: 0101
Study First Received: May 26, 2006
Results First Received: January 28, 2009
Last Updated: August 29, 2016

Additional relevant MeSH terms:
Myocardial Infarction
Angina Pectoris
Angina, Unstable
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on April 28, 2017