A Phase 2/3 interventional study of Near Infrared Spectroscopy (NIRS) Imaging and intravascular ultrasound (IVUS) in Angina Pectoris, Angina, Unstable and Myocardial Infarction, sponsored by Infraredx. Completed at 6 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-05.
Sponsored by Infraredx · Phase 2/3, Interventional, and Diagnostic
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).
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.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's enrollment of 106 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Infraredx is the lead sponsor of 8 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects undergoing elective percutaneous coronary intervention
Device: Near Infrared Spectroscopy (NIRS) Imaging · Device: intravascular ultrasound (IVUS)
Near infrared spectroscopic imaging of the coronary artery with an intravascular spectroscopy catheter.
Also known as: InfraReDx, LipiScan (prototype)
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.
Also known as: Volcano, Revolution, Volcano, Eagle Eye, Boston Scientific, Atlantis
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
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
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
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
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
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.
| Milestone | Intravascular Coronary Imaging |
|---|---|
| Started | 106 |
| 7 day phone contact | 99 |
| 1 year phone contact | 89 |
| Completed | 89 |
| Not completed | 17 |
| Withdrew: Lost to follow-up | 6 |
| Withdrew: Physician decision | 9 |
| Withdrew: Death | 1 |
| Withdrew: Ivus could not be performed. | 1 |
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.
| percent similarity | Intravascular Coronary Imaging |
|---|---|
| Spectral Similarity | 83 (70 to 93) |
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.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
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.
| participants | Intravascular Coronary Imaging |
|---|---|
| Myocardial Infarction | 0 |
| Target Vessel Revascularization | 0 |
| Death | 0 |
| Cerebral Vascular Accident | 0 |
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.
Results for this outcome have not been posted.
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intravascular Coronary Imaging | — | — | — |
| Event | Intravascular Coronary Imaging |
|---|---|
| Myocardial InfarctionCardiac disorders | 8/106 |
| Cerebral Vascular AccidentNervous system disorders | 1/106 |
| DeathCardiac disorders | 1/106 |
| Event | Intravascular Coronary Imaging |
|---|---|
| Chest Pain/Shortness of BreathCardiac disorders | 20/106 |
| Age, Categorical(Participants) | Intravascular Coronary Imaging |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 65 |
| >=65 years | 41 |
| Age, Continuous(years) | Intravascular Coronary Imaging |
|---|---|
| Mean | 61.67 ± 9.96 |
| Sex: Female, Male(Participants) | Intravascular Coronary Imaging |
|---|---|
| Female | 20 |
| Male | 86 |
| Region of Enrollment(participants) | Intravascular Coronary Imaging |
|---|---|
| United States | 79 |
| Canada | 27 |
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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