Indocyanine Green Fluorescence Uptake in Human Carotid Artery Plaque

Completed · Phase 1

Conditions studied: Atherosclerosis, Atherosclerotic Plaque, Carotid Stenosis

In brief

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.

Key facts

Study ID

NCT01873716

Run by

Massachusetts General Hospital

People needed

5

Starts

2013-05-01

Expected to finish

2016-01-01

Last updated by the study team

2017-02-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Consecutive patients scheduled for elective carotid endarterectomy at Massachusetts General Hospital
• Age > 18 years of age.
• Signed informed consent.

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.