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SPECTACL: SPECTroscopic Assessment of Coronary Lipid (SPECTACL)

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ClinicalTrials.gov Identifier: NCT00330928
Recruitment Status : Completed
First Posted : May 29, 2006
Results First Posted : May 28, 2009
Last Update Posted : October 10, 2016
Sponsor:
Information provided by:
InfraReDx

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Angina Pectoris
Angina, Unstable
Myocardial Infarction
Interventions Device: Near Infrared Spectroscopy (NIRS) Imaging
Device: intravascular ultrasound (IVUS)
Enrollment 106
Recruitment Details Subjects were recruited from patients presenting to the cardiac catheterization laboratory for scheduled elective percutaneous coronary intervention. Subject's medical history and angiographic coronary anatomy were used to evaluate eligibility.
Pre-assignment Details  
Arm/Group Title Intravascular Coronary Imaging
Hide Arm/Group Description Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
Period Title: Overall Study
Started 106 [1]
7 Day Phone Contact 99
1 Year Phone Contact 89
Completed 89
Not Completed 17
Reason Not Completed
Lost to Follow-up             6
Physician Decision             9
Death             1
IVUS could not be performed.             1
[1]
Subjects that signed consent and were subject to research procedures.
Arm/Group Title Intravascular Coronary Imaging
Hide Arm/Group Description Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
Overall Number of Baseline Participants 106
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants
<=18 years
0
   0.0%
Between 18 and 65 years
65
  61.3%
>=65 years
41
  38.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 106 participants
61.67  (9.96)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants
Female
20
  18.9%
Male
86
  81.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 106 participants
United States 79
Canada 27
1.Primary Outcome
Title Spectral Similarity
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
58 Subjects were excluded from endpoint analysis for No NIRS data(17), Inadequate data per protocol(11), and Data Accessible during comparison set generation(30).A similarity success was met if >80% of the NIRS data for a subject was similar to the autopsy NIRS set.
Arm/Group Title Intravascular Coronary Imaging
Hide Arm/Group Description:
Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
Overall Number of Participants Analyzed 48
Mean (95% Confidence Interval)
Unit of Measure: percent similarity
83
(70 to 93)
2.Secondary Outcome
Title Review of Lipid Core Plaque of Interest Near Infrared Signals Observed at Baseline in Patients With Stable Angina vs Acute Coronary Syndromes
Hide 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
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Identification of Distinct Near Infrared Spectral Characteristics Associated With Special Coronary Artery Features Identified by Angiography and/or Intravascular Ultrasound and Patient Characteristics
Hide Description [Not Specified]
Time Frame Baseline
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Clinical Cardiac Events Definitely Attributable to the Study Device That Occur From Enrollment to 7 Days Post Enrollment
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients that were enrolled, intent to treat population, were evaluated for definite or probable relation to the investigational device. This includes 7 subjects that were not exposed to the investigational device.
Arm/Group Title Intravascular Coronary Imaging
Hide Arm/Group Description:
Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
Overall Number of Participants Analyzed 106
Measure Type: Number
Unit of Measure: participants
Myocardial Infarction 0
Target Vessel Revascularization 0
Death 0
Cerebral Vascular Accident 0
5.Secondary Outcome
Title Cardiac Events That Occur Within 1 Year Post Enrollment Will be Examined for Link to Lipid Signals.
Hide 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
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intravascular Coronary Imaging
Hide Arm/Group Description Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
All-Cause Mortality
Intravascular Coronary Imaging
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Intravascular Coronary Imaging
Affected / at Risk (%) # Events
Total   10    
Cardiac disorders   
Myocardial Infarction   8/106 (7.55%)  9
Death   1/106 (0.94%)  1
Nervous system disorders   
Cerebral Vascular Accident   1/106 (0.94%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Intravascular Coronary Imaging
Affected / at Risk (%) # Events
Total   20    
Cardiac disorders   
Chest Pain/Shortness of Breath   20/106 (18.87%)  28
Indicates events were collected by systematic assessment
Technical limits of the prototype device factored into the data set reduction(28 patients).Data made available to evaluate handling of the device(30 patients) could not be prospectively evaluated for the primary endpoint of Spectral Similarity.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Manager of Clinical Research
Organization: InfraReDx, Inc
Phone: 781-221-0053
Responsible Party: Director of Clinical & Regulatory Affairs, InfraReDx Inc.
ClinicalTrials.gov Identifier: NCT00330928     History of Changes
Other Study ID Numbers: 0101
CL0101
First Submitted: May 26, 2006
First Posted: May 29, 2006
Results First Submitted: January 28, 2009
Results First Posted: May 28, 2009
Last Update Posted: October 10, 2016