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Completed

NCT Number: NCT01873716

Indocyanine Green Fluorescence Uptake in Human Carotid Artery Plaque

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.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Atherosclerotic Plaque Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Stenosis Central Nervous System Diseases Cerebrovascular Disorders Inflammation Nervous System Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Plaque, Atherosclerotic Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indocyanine green

Drug

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

Other names: FDA Application No. (ANDA) 040811

Primary outcomes

  1. Tissue uptake of indocyanine green in carotid plaque

    Time frame: within 3 months after carotid endarterectomy

    Characterize tissue distribution of indocyanine green in human carotid artery specimens after carotid endarterectomy using fluorescence microcopy

Secondary outcomes

  1. Relationship of indocyanine green uptake to carotid plaque histology

    Time frame: within 3 months after carotid endarterectomy

    Analysis of tissue distribution of indocyanine green in human carotid artery specimens after carotid endarterectomy using histopathology

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

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

Acronym: BRIGHT-CEA

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 10, 2013
Registry last updated
Feb 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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