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It was felt that a sufficient number of subjects were enrolled.
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| Name | Class |
|---|---|
| Infraredx | INDUSTRY |
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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.
The aims of this study are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coronary stenting with OCT, NIRS/IVUS | Experimental | All subjects will have Near Infrared Spectroscopy/Intravascular Ultrasound Imaging performed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InfraReDx Lipiscan IVUS | Device | Near Infrared Spectroscopy/Intravascular Ultrasound will be performed following OCT imaging. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Measured one point in time during cardiac catheterization |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Measured at the time of cardiac catheterization |
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Inclusion Criteria:
Patient Characteristics
Lesion Characteristics
General Exclusion Criteria
Lesion Specific Exclusion Criteria These exclusion criteria apply to the target lesion to be imaged by NIRS IVUS.
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| Name | Affiliation | Role |
|---|---|---|
| Ik-Kyung Jang, MD, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Coronary Stenting With OCT, NIRS/IVUS | All subjects will have Near Infrared Spectroscopy/Intravascular Ultrasound Imaging performed. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| COMPLETED |
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| NOT COMPLETED |
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47 subjects did not meet angiographic criteria for participation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects Having NIRS/IVUS and OCT Imaging During PCI. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | % pts with lipid on NIRS and OCT | Measured one point in time during cardiac catheterization |
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| 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). | Per protocol | Posted | Mean | Standard Deviation | mm (LCP length) | Measured at the time of cardiac catheterization | Lesions | Participants |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects Having NIRS/IVUS and OCT Imaging During PCI. | 0 | 17 | 5 | 17 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain post procedure | Musculoskeletal and connective tissue disorders |
| |||
| Non-ischemic chest pain | Musculoskeletal and connective tissue disorders |
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| Post-procedural myocardial infarction | Cardiac disorders |
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| PVCs during NIRS IVUS | Cardiac disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Iris McNulty | Massachusetts General Hospital | 617 726 2612 | imcnulty@partners.org |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| Lesions |
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