Angina Pectoris, Angina, Unstable, Myocardial Infarction
Conditions
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.
Interventions
DEVICENear Infrared Spectroscopy (NIRS) Imaging
Near infrared spectroscopic imaging of the coronary artery with an intravascular spectroscopy catheter.
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.
Sponsors
Infraredx
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Identification of Distinct Near Infrared Spectral Characteristics Associated With Special Coronary Artery Features Identified by Angiography and/or Intravascular Ultrasound and Patient Characteristics | Baseline | — |
| 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. |
| 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. |
Countries
Canada, United States
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.
Participants by arm
| Arm | Count |
|---|---|
| Intravascular Coronary Imaging Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging | 106 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | IVUS could not be performed. | 1 |
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Physician Decision | 9 |
Baseline characteristics
| Characteristic | Intravascular Coronary Imaging |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 41 Participants |
| Age, Categorical Between 18 and 65 years | 65 Participants |
| Age, Continuous | 61.67 years STANDARD_DEVIATION 9.96 |
| Region of Enrollment Canada | 27 participants |
| Region of Enrollment United States | 79 participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 86 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 20 / — |
| serious Total, serious adverse events | 10 / — |
Outcome results
Primary
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.
Time frame: Baseline
Population: 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 | Measure | Value (MEAN) |
|---|---|---|
| Intravascular Coronary Imaging | Spectral Similarity | 83 percent similarity |
Secondary
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.
Time frame: 1 year
Secondary
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.
Time frame: Baseline to 7 day
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intravascular Coronary Imaging | Clinical Cardiac Events Definitely Attributable to the Study Device That Occur From Enrollment to 7 Days Post Enrollment | Myocardial Infarction | 0 participants |
| Intravascular Coronary Imaging | Clinical Cardiac Events Definitely Attributable to the Study Device That Occur From Enrollment to 7 Days Post Enrollment | Target Vessel Revascularization | 0 participants |
| Intravascular Coronary Imaging | Clinical Cardiac Events Definitely Attributable to the Study Device That Occur From Enrollment to 7 Days Post Enrollment | Death | 0 participants |
| Intravascular Coronary Imaging | Clinical Cardiac Events Definitely Attributable to the Study Device That Occur From Enrollment to 7 Days Post Enrollment | Cerebral Vascular Accident | 0 participants |
Secondary
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
Secondary
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.
Time frame: Baseline