SPECTACL: SPECTroscopic Assessment of Coronary Lipid

• Sponsor: Infraredx (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00330928
• Collaborator: (none)
• Enrollment: 106
• Locations: 6
• Arm: 1
• Duration (Months): 33
• Patients Per Site: 17.7
• Patients Per Site Per Month: 0.5

Study Details

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).

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

• Study Type: Interventional
• 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: Jan 1, 2006
• Actual Primary Completion Date: Oct 1, 2007
• Actual Study Completion Date: Oct 1, 2008

Arms and Interventions

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 Names: 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

Primary Outcome Measures

1. Spectral Similarity [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 [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 [Baseline]

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

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
2	Lahey Clinic	Burlington	Massachusetts	United States	01805
3	William Beaumont Hospital	Royal Oak	Michigan	United States	48073
4	Columbia University Medical Center	New York	New York	United States	10032
5	Duke Medical Center	Durham	North Carolina	United States	27705
6	Montreal Heart Institute	Montreal	Quebec	Canada	H1T 1C8

Sponsors and Collaborators

• Infraredx

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00330928
• Other Study ID Numbers: 0101; CL0101
• First Posted: May 29, 2006
• Last Update Posted: Jan 5, 2021
• Last Verified: Dec 1, 2020

• Additional relevant MeSH terms: Myocardial Infarction; Angina Pectoris; Angina, Unstable; Infarction

Study Results

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.

Arm/Group Title	Intravascular Coronary Imaging
Arm/Group Description	Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
Period Title: Overall Study
STARTED	106
7 Day Phone Contact	99
1 Year Phone Contact	89
COMPLETED	89
NOT COMPLETED	17

Baseline Characteristics

Arm/Group Title	Intravascular Coronary Imaging
Arm/Group Description	Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
Overall Participants	106
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	65 61.3%
>=65 years	41 38.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.67 (9.96)
Sex: Female, Male (Count of Participants)
Female	20 18.9%
Male	86 81.1%
Region of Enrollment (participants) [Number]
United States	79 74.5%
Canada	27 25.5%

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
Measure Participants	48
Mean (95% Confidence Interval) [percent similarity]	83

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

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

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
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

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
Measure Participants	106
Myocardial Infarction	0 0%
Target Vessel Revascularization	0 0%
Death	0 0%
Cerebral Vascular Accident	0 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

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Intravascular Coronary Imaging
	Affected / at Risk (%)	# Events
Total	10/ (NaN)
Cardiac disorders
Myocardial Infarction	8/106 (7.5%)	9
Death	1/106 (0.9%)	1
Nervous system disorders
Cerebral Vascular Accident	1/106 (0.9%)	1
Other (Not Including Serious) Adverse Events
	Intravascular Coronary Imaging
	Affected / at Risk (%)	# Events
Total	20/ (NaN)
Cardiac disorders
Chest Pain/Shortness of Breath	20/106 (18.9%)	28

Limitations/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.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.