Indocyanine Green Fluorescence Uptake in Human Carotid Artery Plaque

Study Overview
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Brief Summary
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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.

Official Title
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Indocyanine Green Fluorescence Uptake in Human Carotid Artery Plaque -- A Pilot Study

Conditions
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Atherosclerosis, Atherosclerotic Plaque, Carotid Stenosis

Intervention / Treatment
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* Drug: Indocyanine green


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consecutive patients scheduled for elective carotid endarterectomy at Massachusetts General Hospital Age > 18 years of age. Signed informed consent. Exclusion criteria: Hemodynamic instability Any history of iodide allergy Any history of renal failure (estimated Glomerular Filtration Rate (eGFR) <50 ml/min/1.73 m2) Any history of liver failure Any history of bleeding diathesis Any history of cerebral vascular accident in the preceding 3 months Pregnant or lactating females. Hx of seafood allergy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Injection of Indocyanine Green<br>Injection of Indocyanine Green prior to carotid endarterectomy surgery. Collection of specimen during surgery with subsequent carotid tissue analysis. | Drug: Indocyanine green<br>* Indocyanine green (ICG) for injection, 0.25mg/kg intravenously. A maximum of 25mg is given, approximately 30-60 minutes before carotid endarterectomy<br>* Other names: FDA Application No. (ANDA) 040811;|
| No Intervention: No injection<br>No injection prior to carotid endarterectomy surgery. Collection of specimen during surgery with subsequent carotid tissue analysis. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atherosclerosis, Molecular Imaging, Vascular Biology, Inflammation, Fluorescence