Indocyanine Green Fluorescence Uptake in Human Carotid Artery Plaque

Atherosclerosis Clinical Trial

— BRIGHT-CEA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01873716
• Other study ID #: 2012P000895
• Status: Completed
• Phase: Phase 1
• First received: May 23, 2013
• Last updated: January 31, 2017
• Start date: May 2013
• Est. completion date: January 2016

Study information

• Verified date: January 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerotic Plaque
• Carotid Stenosis
• Plaque, Atherosclerotic

Intervention

Drug:
• Indocyanine green
Indocyanine green (ICG) for injection, 0.25mg/kg intravenously. A maximum of 25mg is given, approximately 30-60 minutes before carotid endarterectomy

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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