Atherosclerosis Clinical Trial
— BRIGHT-CEAOfficial title:
Indocyanine Green Fluorescence Uptake in Human Carotid Artery Plaque -- A Pilot Study
Verified date | January 2017 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 5 |
Est. completion date | January 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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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