Indocyanine Green Fluorescence Uptake in Human Carotid Artery Plaque
NCT ID: NCT01873716
Last Updated: 2017-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
5 participants
INTERVENTIONAL
2013-05-31
2016-01-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Injection of Indocyanine Green
Injection of Indocyanine Green prior to carotid endarterectomy surgery. Collection of specimen during surgery with subsequent carotid tissue analysis.
Indocyanine green
Indocyanine green (ICG) for injection, 0.25mg/kg intravenously. A maximum of 25mg is given, approximately 30-60 minutes before carotid endarterectomy
No injection
No injection prior to carotid endarterectomy surgery. Collection of specimen during surgery with subsequent carotid tissue analysis.
No interventions assigned to this group
Interventions
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Indocyanine green
Indocyanine green (ICG) for injection, 0.25mg/kg intravenously. A maximum of 25mg is given, approximately 30-60 minutes before carotid endarterectomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \> 18 years of age.
* Signed informed consent.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Farouc Amin Jaffer
Associate Professor of Medicine, Harvard Medical School
Principal Investigators
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Farouc A Jaffer, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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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.
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.
Other Identifiers
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2012P000895
Identifier Type: -
Identifier Source: org_study_id
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