Indocyanine Green Fluorescence Uptake in Human Carotid Artery Plaque

Phase 1

Completed

• Conditions: Atherosclerosis; Atherosclerotic Plaque; Carotid Stenosis
• Interventions: Drug: Indocyanine green

• Registration Number: NCT01873716
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-23
• Study First Submitted QC: 2013-06-06
• Study First Posted: 2013-06-10
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Injection of Indocyanine Green	Indocyanine green	Injection of Indocyanine Green prior to carotid endarterectomy surgery. Collection of specimen during surgery with subsequent carotid tissue analysis.

Primary Outcome Measures

Name	Time	Method
Tissue uptake of indocyanine green in carotid plaque	within 3 months after carotid endarterectomy	Characterize tissue distribution of indocyanine green in human carotid artery specimens after carotid endarterectomy using fluorescence microcopy

Secondary Outcome Measures

Name	Time	Method
Relationship of indocyanine green uptake to carotid plaque histology	within 3 months after carotid endarterectomy	Analysis of tissue distribution of indocyanine green in human carotid artery specimens after carotid endarterectomy using histopathology

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States