Gluteal Claudication, Intermittent Claudication, Peripheral Arterial Disease, Peripheral Vascular Diseases
Conditions
Keywords
Peripheral Vascular Diseases, Peripheral Arterial Disease, Peripheral Artery Disease, PAD, Gluteal claudication, Buttock claudication, MSOT, Multispectral Optoacoustic Tomography
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTMSOT
Non-invasive transcutaneous imaging of muscle components via infrared and near-infrared laser pulses
Sponsors
Ulrich Rother
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Perfusion parameters from MSOT would be measured on patients with gluteal claudication in Fontain stage 2 before and after the revascularisation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Patient with gluteal claudication in Fontaine stage II and corresponding stenosis (common iliac artery, internal iliac artery or distal aorta)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Optimal diagnostic MSOT thresholds | 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 |
| Improvement of the MSOT parameters after the revascularisation | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of acquired MSOT parameters with the CCDS flow profile and PSV | single time point | Hemoglobin-associated MSOT parameters in patients with gluteal claudication correlated with the flow profile and PSV of A. femoralis communis and A. poplitea determined by CCDS |
| Correlation of acquired MSOT parameters with the ABI | twice (before and after the intervention, up to two weeks) | Hemoglobin-associated parameters derived by transcutaneous MSOT correlated with the ABI |
| Correlation of acquired MSOT parameters with threadmill test | twice (before and after the intervention, up to two weeks) | Hemoglobin-associated MSOT parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT correlated with Threadmill test |
| Difference between the corresponding MSOT values before and after exercis | twice (before and after the intervention, up to two weeks) | Difference of the values before and after exercise for hemoglobin-associated parameters derived by transcutaneous MSOT in patients with gluteal claudication |
| 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) | hemoglobin-associated MSOT parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT correlated with the perceived PAD-specific quality of life (VASCUQOL-6 questionnaire) |
| Correlation of acquired MSOT parameters with the TASC-classification (angiography) | twice (before and after the intervention, up to two weeks) | hemoglobin-associated MSOT parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT in patients with PAD in Fontaine stage II correlated with the TASC-classification (angiography) |
| Confounder analysis | twice (before and after the intervention, up to two weeks) | Correlation of all collected parameters (anamnestic, demographic, physiological) with regard to their characteristics as basic confounders for the MSOT technique |
| Correlation of acquired MSOT parameters with subjectively perceived maximum walking distance in everyday life | twice (before and after the intervention) | hemoglobin-associated MSOT parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT correlated with the subjectively perceived maximum walking distance in everyday life |
| Reperfusion profiles for hemoglobin-associated parameters | twice (before and after the intervention, up to two weeks) | Curves of hemoglobin-associated MSOT parameters in the first ten minutes after exercise |
Countries
Germany
Outcome results
None listed