Evaluation of Gluteal Muscle Perfusion in Patients With Intermittent Gluteal Claudication by Non-invasive Multispectral Optoacoustic Tomography With Pre-post Study Design
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Improvement of the MSOT parameters after the revascularisation
研究概览
简要总结
The objective of the proposed study is to define independent parameters for the diagnostic assessment of the perfusion situation of the gluteal muscle based on multispectral optoacoustic tomography (MSOT) in patients with gluteal claudication in Fontaine stage II (intermittent claudication) pre and post-intervention.
详细描述
This is a monocentric, prospective study which aims to exanimate the optoacoustic signals in gluteal muscle after a exercise in patients with PAD in Fontaine stage II before and after the revascularisation to verify the change of MSOT by improved vascularization. MSOT data will be correlated with CCDS, ABI, treadmill test, 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 gluteal claudication in Fontaine stage II will be recruited during the consulting hours of the Department of Vascular Surgery, University Hospital Erlangen. 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 MSOT parameters will be recorded on gluteal muscles before and after a stepper exercise two minutes or until the occurrence of claudication pain in the gluteal muscle. The more affected side is examined. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Patient with gluteal claudication in Fontaine stage II and corresponding stenosis (common iliac artery, internal iliac artery or distal aorta)
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
Improvement of the MSOT parameters after the revascularisation
时间窗: twice (before and after the intervention, up to two weeks)
Change of hemoglobin-associated MSOT parameters in gluteal muscle tissue in patients with intermittent claudication before and after exercise after the revascularisation
Optimal diagnostic MSOT thresholds
时间窗: twice (before and after the intervention, up to two weeks)
optimal diagnostic threshold for hemoglobin-associated MSOT parameters in gluteal muscle tissue in patients with intermittent claudication before and after exercise
次要结局
- Correlation of acquired MSOT parameters with subjectively perceived maximum walking distance in everyday life(twice (before and after the intervention))
- Correlation of acquired MSOT parameters with the perceived PAD-specific quality of life (VASCUQOL-6 questionnaire)(twice (before and after the intervention, up to two weeks))
- Difference between the corresponding MSOT values before and after exercis(twice (before and after the intervention, up to two weeks))
- Correlation of acquired MSOT parameters with the TASC-classification (angiography)(twice (before and after the intervention, up to two weeks))
- Reperfusion profiles for hemoglobin-associated parameters(twice (before and after the intervention, up to two weeks))
- Correlation of acquired MSOT parameters with the CCDS flow profile and PSV(single time point)
- Correlation of acquired MSOT parameters with the ABI(twice (before and after the intervention, up to two weeks))
- Correlation of acquired MSOT parameters with threadmill test(twice (before and after the intervention, up to two weeks))
- Confounder analysis(twice (before and after the intervention, up to two weeks))
研究者
Ulrich Rother
PD Dr. med.
University Hospital Erlangen