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SPECTACL: SPECTroscopic Assessment of Coronary Lipid (SPECTACL)

Primary Purpose

Angina Pectoris, Angina, Unstable, Myocardial Infarction

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Near Infrared Spectroscopy (NIRS) Imaging
intravascular ultrasound (IVUS)
Sponsored by
Infraredx
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Angina Pectoris

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beth Israel Deaconess Medical Center
  • Lahey Clinic
  • William Beaumont Hospital
  • Columbia University Medical Center
  • Duke Medical Center
  • Montreal Heart Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Subjects undergoing elective percutaneous coronary intervention

Outcomes

Primary Outcome Measures

Spectral Similarity
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
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
Clinical Cardiac Events Definitely Attributable to the Study Device That Occur From Enrollment to 7 Days Post Enrollment
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.
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.

Full Information

First Posted
May 26, 2006
Last Updated
December 10, 2020
Sponsor
Infraredx
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1. Study Identification

Unique Protocol Identification Number
NCT00330928
Brief Title
SPECTACL: SPECTroscopic Assessment of Coronary Lipid
Acronym
SPECTACL
Official Title
Coronary Artery Plaque Characterization by NIR Spectroscopy in Patients Undergoing Elective Percutaneous Coronary Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Infraredx

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angina Pectoris, Angina, Unstable, Myocardial Infarction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Subjects undergoing elective percutaneous coronary intervention
Intervention Type
Device
Intervention Name(s)
Near Infrared Spectroscopy (NIRS) Imaging
Other Intervention Name(s)
InfraReDx, LipiScan (prototype)
Intervention Description
Near infrared spectroscopic imaging of the coronary artery with an intravascular spectroscopy catheter.
Intervention Type
Device
Intervention Name(s)
intravascular ultrasound (IVUS)
Other Intervention Name(s)
Volcano, Revolution, Volcano, Eagle Eye, Boston Scientific, Atlantis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Spectral Similarity
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Review of Lipid Core Plaque of Interest Near Infrared Signals Observed at Baseline in Patients With Stable Angina vs Acute Coronary Syndromes
Description
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.
Time Frame
Baseline
Title
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
Title
Clinical Cardiac Events Definitely Attributable to the Study Device That Occur From Enrollment to 7 Days Post Enrollment
Description
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.
Time Frame
Baseline to 7 day
Title
Cardiac Events That Occur Within 1 Year Post Enrollment Will be Examined for Link to Lipid Signals.
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergio Waxman, MD
Organizational Affiliation
Lahey Clinic, Burlington, MA, USA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Lahey Clinic
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Duke Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
19608137
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.
Results Reference
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SPECTACL: SPECTroscopic Assessment of Coronary Lipid

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