Multistructural Quantitative Photoacoustic Imaging of Human Feet With Lower Extremity Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Mean vessel density of foot vasculature measured by photoacoustic imaging
研究概览
简要总结
Lower extremity artery disease (LEAD) is characterized by low awareness rate and high missed diagnosis rate, leading to low treatment rate and high disabling mortality rate. However, none of the current examination methods can comprehensively and thoroughly evaluate the vascular structure and blood oxygen status of the lower extremity at the same time. Photoacoustic imaging can display millimeter-scale microvessels without the need for contrast agents. The investigators developed photoacoustic tomography (PACT) technology, which wass able to provide three-dimensional and high-resolution photoacoustic images of the target area.The investigators plan to recruit LEAD patients in different disease conditions and healthy volunteers to receive the PACT examination on the feet using this imaging system, and to evaluate the potential clinical role of the imaging system in LEAD, and its added value to current imaging methods.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Inclusion of the case group 1) LEAD patients; 2) Patients voluntarily take part in the study and write informed consent.
- •Inclusion of the control group 1) Patients without LEAD by ultrasound and clinical diagnosis; 2) Patients voluntarily take part in the study and write informed consent.
排除标准
- •age <18 years;
- •pregnant women, nursing mothers and pregnant women in preparation;
- •with laser operation contraindication (for example, received a photodynamic therapy in the last month);
- •with metal implants in lower legs or feet;
- •with a history of mental illnesses or abuse of drug and alcohol;
- •7) with blood phobia or pathological hypotension; 8) with cerebral hemorrhage or peripheral vascular bleeding risk, or history of stroke; 9) with wounds in lower legs or feet; 10) unable or uncooperative with the experimenter.
结局指标
主要结局
Mean vessel density of foot vasculature measured by photoacoustic imaging
时间窗: Baseline
Vessel density (number of vessels per mm²) in foot vasculature will be quantified using photoacoustic imaging. Results will be reported as mean ± SD.
次要结局
- Mean oxygen saturation in pedal vasculature measured by photoacoustic imaging(Baseline)
- Mean hemoglobin concentration in pedal vasculature measured by photoacoustic imaging(Baseline)
研究者
Jia Liu
Principal Investigator
Sun Yat-sen University