跳至主要内容
临床试验/NCT03622359
NCT03622359招募中不适用

Radiotracer Imaging of Skeletal Muscle Perfusion in Patients With Peripheral Artery Disease

Nationwide Children's Hospital2 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2017年2月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
192
试验地点
2
主要终点
Lower extremity perfusion

研究概览

简要总结

The aim of this clinical study is to 1) establish a healthy database for nuclear perfusion imaging of the lower extremities and 2) assess the prognostic value of radiotracer-based perfusion imaging for predicting clinical outcomes in patients with peripheral artery disease (PAD) who are undergoing lower extremity revascularization procedures. We hypothesize that radiotracer imaging of the lower extremities will provide a sensitive non-invasive imaging tool for quantifying regional abnormalities in skeletal muscle perfusion and evaluating responses to medical treatment.

详细描述

PAD patients (n=80) with peripheral artery disease (PAD) who are scheduled to undergo lower extremity revascularization procedures will be recruited. Patients will be screened using a standard medical history questionnaire and a physical activity questionnaire. Once their questionnaires are reviewed, individuals who meet inclusion criteria will proceed with standard PAD screening, which will include Ankle-Brachial Indices (ABIs) and Toe-Brachial Indices (TBIs) of both lower extremities. Patients will undergo SPECT/CT or PET/CT perfusion imaging prior to their revascularization procedure and 1-14 days following revascularization. Subjects will receive an intravenous injection of a standard clinical dose of radiotracer for both imaging sessions. A low-dose CT scan will be performed immediately after each SPECT and PET image acquisition for the purposes of attenuation correction and regional analysis of radiotracer uptake. Clinical outcomes will be evaluated for up to 12 months after the imaging study to assess the prognostic value of perfusion imaging for predicting subsequent outcomes. An additional subset of PAD patients (n=56) and healthy control subjects (n=56) will be enrolled to undergo the same imaging procedures to establish a healthy database for PET perfusion imaging measures.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Lower extremity perfusion

时间窗: 1-2 weeks

The percent or absolute change in perfusion from baseline to post-revascularization will be evaluated.

次要结局

  • Wound healing(1 year)
  • Limb salvage(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mitchel Stacy

Principal Investigator / Assistant Professor

Nationwide Children's Hospital

研究点 (2)

Loading locations...

相似试验

Radiotracer-Based Perfusion Imaging of Patients With... | 临床试验