SPECTACL: SPECTroscopic Assessment of Coronary Lipid (SPECTACL)

• 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: InfraReDx
• 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

Participant Flow

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
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.

Baseline Characteristics

Arm/Group Title		Intravascular Coronary Imaging
Arm/Group Description		Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
Overall Number of Baseline Participants		106
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

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

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
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
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
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
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

Outcome Measure Data

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
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.
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

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Intravascular Coronary Imaging
Arm/Group Description	Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
All-Cause Mortality
	Intravascular Coronary Imaging
	Affected / at Risk (%)
Total	--/--
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
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

Limitations and Caveats

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.

More Information

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: Director Clinical and Regulatory
• Organization: InfraReDx, Inc
• Phone: 781-221-0053
• EMail: pshah@infraredx.com

Publications of Results:

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.

• Responsible Party: Director of Clinical & Regulatory Affairs, InfraReDx Inc.
• ClinicalTrials.gov Identifier: NCT00330928
• 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: January 5, 2021