Indocyanine Green Fluorescence Uptake in Human Carotid Artery Plaque -- A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Tissue uptake of indocyanine green in carotid plaque
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Injection of Indocyanine Green
Injection of Indocyanine Green prior to carotid endarterectomy surgery. Collection of specimen during surgery with subsequent carotid tissue analysis.
干预措施: Indocyanine green (Drug)
结局指标
主要结局
Tissue uptake of indocyanine green in carotid plaque
时间窗: within 3 months after carotid endarterectomy
Characterize tissue distribution of indocyanine green in human carotid artery specimens after carotid endarterectomy using fluorescence microcopy
次要结局
- Relationship of indocyanine green uptake to carotid plaque histology(within 3 months after carotid endarterectomy)
研究者
Farouc Amin Jaffer
Associate Professor of Medicine, Harvard Medical School
Massachusetts General Hospital