Cross-sectional Study of Calf Muscle Perfusion Via 3D Reconstruction of Multispectral Optoacoustic Tomography in Patients With Peripheral Arterial Disease After Exercise.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Optimal diagnostic MSOT thresholds
研究概览
简要总结
The aim of the proposed study is to define independent parameters for the diagnostic assessment of the perfusion situation of the calf muscle based on 3D-reconstruction of multispectral optoacoustic tomography (MSOT) in a cross-sectional collective of patients with PAD in Fontaine stage II and a healthy control group.
详细描述
This is a monocentric, prospective cross-sectional study which aims to compare the 3D-reconstructed optoacoustic signals in calf muscle after a exercise in patients with PAD in Fontaine stage II and a healthy control group in order to define MSOT thresholds. MSOT data will be correlated with CCDS, ABI, maximum walking distance in 6MWT, subjectively perceived absolute walking distance in everyday life, PAD-related life quality (VASCUQOL-6) and TASC II classification in angiographic imaging (only in case angiographic imaging is available and independent from this study).
Patients with intermittent claudication will be recruited during the consulting hours of the Department of Vascular Surgery, University Hospital Erlangen. Healthy volunteers will be acquired via posters in the clinic. Following detailed information about the study and after providing written consent, relevant clinical data will be collected from the electronical patient file, if available. In addition, a thorough anamnesis interview for relevant data and CCDS would be performed. Afterwards, the 3D-reconstructed parameters will be recorded by means of longitudinal MSOT scans before and after a heel raise exercise until the occurrence of claudication pain in the calf muscle. For patients with PAD, the more affected leg is examined. In healthy volunteers, either leg is examined. ABI would be measured before and after 6MWT. All data will be adequately pseudonymized in compliance with data protection regulations before they are used for statistical analysis. The duration of the study for participants will be max. 90 minutes. The angiographic imaging will be reviewed and analyzed (if available, independently from this study and the interval between MSOT measurement being lesser than 12 months). The complete study including the validation of the data by an independent study group is expected to be finished within one year.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Patients with PAD in Fontaine stage II or Rutherford category 1-3 or healthy volunteers
- •Adults (>18 years) who are able to give their consent
排除标准
- •Patients with PAD in Fontaine stage I, III and IV or Rutherford category 0, 4, 5 and 6 or healthy volunteers with diabetes mellitus, chronic renal failure, claudication symptoms, abnormal ABI or non-palpable foot pulses
- •People with age under 18
- •Absence of written consent
- •Safety concerns of the study physician (person with physical, mental or psychiatric conditions which, by the judgement of the study physician, would compromise the person's safety or the quality of the data, thereby rendering the person an ineligible candidate for the study
结局指标
主要结局
Optimal diagnostic MSOT thresholds
时间窗: single time point (1 day)
Quantitative oxygenated hemoglobin signal in 3D-reconstruction (in arbitrary units). \[This target variable is collected non-invasively using MSOT\].
次要结局
- Correlation of acquired 3D-reconstructed MSOT parameters with the subjectively perceived maximum walking distance in everyday life(single time point (1 day))
- Confounder analysis(single time point (1 day))
- Reperfusion profiles of hemoglobin-associated 3D-reconstructed MSOT parameters(single time point (1 day))
- Correlation of acquired 3D-reconstructed MSOT parameters with the CCDS flow profiles and PSVs(single time point (1 day))
- Correlation of acquired 3D-reconstructed MSOT parameters with the ABI(single time point (1 day))
- Correlation of acquired 3D-reconstructed MSOT parameters with relative (until the first occurrence of pain) and absolute walking distance (until the first stopping due to pain) determined during the 6MWT(single time point (1 day))
- Correlation of acquired 3D-reconstructed MSOT parameters with the perceived PAD-specific quality of life (VASCUQOL-6 questionnaire)(single time point (1 day))
- Difference between the corresponding 3D-reconstructed MSOT values before and after exercise(single time point (1 day))
- Correlation of the acquired 3D-reconstructed MSOT parameters with the TASC-classification (angiography)(single time point (1 day))
- Correlation of acquired 3D-reconstructed MSOT parameters with maximum walking distance in the 6MWT(single time point (1 day))
研究者
Ulrich Rother
PD Dr. med.
University Hospital Erlangen