Arterial Imaging of Inflammation and Resolution After Endovascular Surgery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Changes found in the quantitative measure of FDG-PET uptake at intervention site prior to and after peripheral vascular injury.
研究概览
简要总结
This study evaluates the local inflammatory and resolution response of patients undergoing peripheral vascular intervention like an angioplasty of the superficial femoral artery (SFA) or popliteal artery, or stenting of the iliac artery or SFA, through the use of Positron emission tomography-magnetic resonance imaging (PET/MRI). PET/MRI will be performed prior to intervention, one day and one week after intervention.
详细描述
Magnetic resonance imaging (MRI) imaging allows for non-invasive visualization of anatomical structures while Positron emission tomography (PET) scans allow for the observation of molecular and cellular activities. Using a PET/MRI in patients with vascular injury post intervention with help evaluate the vascular inflammatory and resolution response in vivo.
Acute vascular injury through endovascular intervention results in recruitment of inflammatory cells such as macrophages to the vessel wall. Macrophages are very metabolically active and consume glucose at a high rate. In PET/MRI, subjects are injected with 18F-Fluorodeoxyglucose (18F-FDG), a radioactively labeled glucose molecule which is consumed by macrophages.
When 18F-FDG is consumed, it is retained within macrophages more avidly than other atherosclerotic lesion elements. Thus, FDG-PET provides a unique and noninvasive approach to quantitatively measure macrophage activity at the intervention site.
This study will provide key pilot data for developing an imaging surrogate endpoint for pro-resolving mediator treatment intervention trials going forward.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over the age of 40,
- •With resting or exercise ABI <0.9, TBI <0.6
- •Have claudication or limb threatening ischemia & planning to undergo a percutaneous angioplasty of SFA or popliteal artery, or stenting of the iliac artery or SFA.
排除标准
- •Evidence of active infection
- •Hypersensitivity or allergy to contrast agents
- •Chronic liver disease, renal disease (GFR< 30) or chronic inflammatory disorders
- •Insulin dependent diabetes
- •Presence of metal within subject's body, pacemakers, or defibrillators
- •BMI < 20 or >35
- •Recent other major surgery or illness within 30 days
- •Use of immunosuppressive medications or steroids
- •History of organ transplantation
- •Pregnancy, or plans to become pregnant, or lactating
研究组 & 干预措施
PET/MR using FDG-18 radiotracer
Using FDG-18 radiotracer, subject undergoes PET/MR scan which detects the uptake of the tracer.
干预措施: 18F-FDG (Drug)
结局指标
主要结局
Changes found in the quantitative measure of FDG-PET uptake at intervention site prior to and after peripheral vascular injury.
时间窗: 1 time each week for 3 weeks
Patient is given 18F-FDG radio tracer. The tracer is quantitatively measured through FDG-PET imaging modality for uptake at the intervention site.
次要结局
- Changes in the correlating the inflammatory and resolution response prior to and after peripheral vascular injury.(1 time each week for 3 weeks)