Coronary Artery Disease
Conditions
Brief summary
The purpose of this study is to learn more about lipid rich plaque using Near Infrared Spectroscopy (NIRS)/Intravascular Ultrasound (IVUS) imaging in patients who have had coronary artery stenting and Optical coherence tomography (OCT) imaging.
Detailed description
The aims of this study are to: 1. Test the ability of the new NIRS IVUS system to detect lipid pool 2. Evaluate the accuracy of the NIRS IVUS system for localization of lipide rich plaque: superficial vs deep 3. Improve diagnostic accuracy of OCT for detection of lipid using information from NIRS IVUS
Interventions
DEVICEInfraReDx Lipiscan IVUS
Near Infrared Spectroscopy/Intravascular Ultrasound will be performed following OCT imaging.
Sponsors
Infraredx
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
Patient Characteristics 1. Males and non-pregnant females \> 18 and \< 79 years of age 2. Patients referred for diagnostic coronary angiography who are found to have lesions in native coronary arteries which will be treated by percutaneous coronary intervention (PCI) (or patients with known coronary lesions who are referred for planned PCI) 3. Able to give written informed consent Lesion Characteristics 1. Lesion in native coronary artery 2. Angiographic stenosis \> 50% 3. Reference vessel diameter 2.5 mm - 4.0 mm by visual estimation 4. Subjects who have successful PCI and OCT General
Exclusion criteria
1. Subjects who are unable or unwilling to sign the informed consent form 2. Subjects with serious co-morbid conditions that in judgment of the investigator preclude inclusion in this study (such as terminal cancer, life expectancy \< 6 months, Liver Function Tests (LFTs) \> 3 times Upper Limit of Normal (ULN), or post-transplant) 3. Subjects with New York Heart Association (NYHA) class III or IV heart failure or known left ventricular ejection fraction \< 30% 4. Subjects who have experienced an ST-elevation myocardial infarction (STEMI) within 72 hours prior to the procedure 5. Subjects with hemodynamic or electrical instability (including shock) 6. Subjects diagnosed with severe, non-catheter-related coronary artery spasm 7. Subjects who are or may be pregnant 8. Subjects with known allergies to contrast media 9. Subjects with renal failure as defined by estimated Glomerular Filtration Rate (eGFR) \< 60. 10. History of Transient Ischemic Attack (TIA) or stroke \< 6 months Lesion Specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of Lipid Rich Plaque by Near Infrared Spectroscopy (NIRS) Intravascular Ultrasound (IVUS) | Measured one point in time during cardiac catheterization | Subjects are presenting for their clinically-indicated cardiac catheterization. NIRS/IVUS imaging will be done at the time of catheterization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in NIRS Parameters Between Deep and Superficial Lipid Assessed by Optical Coherence Tomography (OCT). | Measured at the time of cardiac catheterization | Subjects are presenting for their clinically-indicated cardiac catheterization. NIRS/IVUS imaging will be done at the time of catheterization. Plaques were divided depending on depth of lipid by OCT (cut off value 130 um). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subjects Having NIRS/IVUS and OCT Imaging During PCI. | 17 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not meet angiographic criteria | 47 |
Baseline characteristics
| Characteristic | Subjects Having NIRS/IVUS and OCT Imaging During PCI. |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants |
| Age Continuous | 59.8 years STANDARD_DEVIATION 8.5 |
| Region of Enrollment United States | 17 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
Primary
Detection of Lipid Rich Plaque by Near Infrared Spectroscopy (NIRS) Intravascular Ultrasound (IVUS)
Subjects are presenting for their clinically-indicated cardiac catheterization. NIRS/IVUS imaging will be done at the time of catheterization.
Time frame: Measured one point in time during cardiac catheterization
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subjects Having NIRS/IVUS and OCT Imaging During PCI. | Detection of Lipid Rich Plaque by Near Infrared Spectroscopy (NIRS) Intravascular Ultrasound (IVUS) | 90 % pts with lipid on NIRS and OCT |
Secondary
Differences in NIRS Parameters Between Deep and Superficial Lipid Assessed by Optical Coherence Tomography (OCT).
Subjects are presenting for their clinically-indicated cardiac catheterization. NIRS/IVUS imaging will be done at the time of catheterization. Plaques were divided depending on depth of lipid by OCT (cut off value 130 um).
Time frame: Measured at the time of cardiac catheterization
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Subjects Having NIRS/IVUS and OCT Imaging During PCI. | Differences in NIRS Parameters Between Deep and Superficial Lipid Assessed by Optical Coherence Tomography (OCT). | 5.5 mm (LCP length) | Standard Deviation 2.8 |
| Deep Lipid | Differences in NIRS Parameters Between Deep and Superficial Lipid Assessed by Optical Coherence Tomography (OCT). | 4.1 mm (LCP length) | Standard Deviation 3.1 |