Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

SPECTACL: SPECTroscopic Assessment of Coronary Lipid (SPECTACL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00330928
Recruitment Status : Completed
First Posted : May 29, 2006
Results First Posted : May 28, 2009
Last Update Posted : January 5, 2021
Sponsor:
Information provided by:
InfraReDx

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment Phase
Angina Pectoris Angina, Unstable Myocardial Infarction Device: Near Infrared Spectroscopy (NIRS) Imaging Device: intravascular ultrasound (IVUS) Phase 2 Phase 3

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Coronary Artery Plaque Characterization by NIR Spectroscopy in Patients Undergoing Elective Percutaneous Coronary Intervention
Study Start Date : January 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2008
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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 ]
  3. 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.

  4. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00330928


Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Sergio Waxman, MD Lahey Clinic, Burlington, MA, USA
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: Director of Clinical & Regulatory Affairs, InfraReDx Inc.
ClinicalTrials.gov Identifier: NCT00330928    
Other Study ID Numbers: 0101
CL0101
First Posted: May 29, 2006    Key Record Dates
Results First Posted: May 28, 2009
Last Update Posted: January 5, 2021
Last Verified: December 2020
Additional relevant MeSH terms:
Layout table for MeSH terms
Myocardial Infarction
Angina Pectoris
Angina, Unstable
Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations