Radiotracer Imaging of Skeletal Muscle Perfusion in Patients With Peripheral Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 192
- 试验地点
- 1
- 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
- 是
入选标准
- •for Patients with Peripheral Artery Disease:
- •At least 18 years of age
- •Evidence of significant obstructive disease for one or multiple lower extremity arteries, as identified by prior ABI, TBI, CT angiography, ultrasound, or MR imaging.
排除标准
- •for Patients with Peripheral Artery Disease:
- •Unable to give informed consent or follow-up
- •Pregnant or nursing
- •Under the age of 18
- •No history of peripheral artery disease
- •Inclusion Criteria for Healthy Control Subjects:
- •At least 18 years of age
- •No evidence or prior diagnosis of peripheral artery disease based on chart review and standard vascular screening.
- •Exclusion Criteria for Healthy Control Subjects:
- •Unable to give informed consent of follow-up
- •Pregnant or nursing
- •Under the age of 18
- •History of peripheral artery disease
研究组 & 干预措施
SPECT/CT perfusion imaging
Patients with peripheral artery disease will have already been scheduled for clinically indicated revascularization procedures of the lower extremity and undergo SPECT/CT imaging as part of the research protocol.
干预措施: SPECT/CT perfusion imaging (Diagnostic Test)
SPECT/CT perfusion imaging
Patients with peripheral artery disease will have already been scheduled for clinically indicated revascularization procedures of the lower extremity and undergo SPECT/CT imaging as part of the research protocol.
干预措施: PET/CT perfusion imaging (Diagnostic Test)
PET/CT perfusion imaging
Patients with peripheral artery disease will have already been scheduled for clinically indicated revascularization procedures of the lower extremity and undergo PET/CT imaging as part of the research protocol.
干预措施: SPECT/CT perfusion imaging (Diagnostic Test)
PET/CT perfusion imaging
Patients with peripheral artery disease will have already been scheduled for clinically indicated revascularization procedures of the lower extremity and undergo PET/CT imaging as part of the research protocol.
干预措施: PET/CT perfusion imaging (Diagnostic Test)
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
Mitchel Stacy
Principal Investigator / Assistant Professor
Nationwide Children's Hospital
