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This will be a pilot study of 9 patients undergoing standard-of-care clinically indicated carotid endarterectomy. The nine patients will receive an injection of Indocyanine green (ICG) at a dose of 0.25 mg/kg (maximum 25 mg) as an intravenous bolus.
Immediately following endarterectomy, the resected specimen will be immersed in normal saline. Ex vivo fluorescence reflectance imaging (FRI) and immunohistochemistry will be performed.
The investigators hypothesize that compared to controls, ICG-injected patients will demonstrate increased ex vivo and microscopic ICG fluorescence signal within areas of plaque.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Injection of Indocyanine Green | Experimental | Injection of Indocyanine Green prior to carotid endarterectomy surgery. Collection of specimen during surgery with subsequent carotid tissue analysis. |
|
| No injection | No Intervention | No injection prior to carotid endarterectomy surgery. Collection of specimen during surgery with subsequent carotid tissue analysis. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine green | Drug | Indocyanine green (ICG) for injection, 0.25mg/kg intravenously. A maximum of 25mg is given, approximately 30-60 minutes before carotid endarterectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tissue uptake of indocyanine green in carotid plaque | Characterize tissue distribution of indocyanine green in human carotid artery specimens after carotid endarterectomy using fluorescence microcopy | within 3 months after carotid endarterectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Relationship of indocyanine green uptake to carotid plaque histology | Analysis of tissue distribution of indocyanine green in human carotid artery specimens after carotid endarterectomy using histopathology | within 3 months after carotid endarterectomy |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Farouc A Jaffer, MD PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21613624 | Background | Vinegoni C, Botnaru I, Aikawa E, Calfon MA, Iwamoto Y, Folco EJ, Ntziachristos V, Weissleder R, Libby P, Jaffer FA. Indocyanine green enables near-infrared fluorescence imaging of lipid-rich, inflamed atherosclerotic plaques. Sci Transl Med. 2011 May 25;3(84):84ra45. doi: 10.1126/scitranslmed.3001577. | |
| 27544892 | Derived |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D058226 | Plaque, Atherosclerotic |
| D016893 | Carotid Stenosis |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Verjans JW, Osborn EA, Ughi GJ, Calfon Press MA, Hamidi E, Antoniadis AP, Papafaklis MI, Conrad MF, Libby P, Stone PH, Cambria RP, Tearney GJ, Jaffer FA. Targeted Near-Infrared Fluorescence Imaging of Atherosclerosis: Clinical and Intracoronary Evaluation of Indocyanine Green. JACC Cardiovasc Imaging. 2016 Sep;9(9):1087-1095. doi: 10.1016/j.jcmg.2016.01.034. Epub 2016 Aug 17. |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |