Investigation of the Perfusion of Gluteal Muscle in Patients With Intermittent Gluteal Claudication by Non-invasive MSOT
- Conditions
- Peripheral Vascular DiseasesIntermittent ClaudicationPeripheral Arterial DiseaseGluteal Claudication
- Interventions
- Diagnostic Test: MSOT
- Registration Number
- NCT06391346
- Lead Sponsor
- Ulrich Rother
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
• Patient with gluteal claudication in Fontaine stage II and corresponding stenosis (common iliac artery, internal iliac artery or distal aorta)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patient MSOT Multispectral Optoacoustic Tomography (MSOT) and B-Mode Ultrasound of the Musculus gluteus of the affected leg in PAD patients in Fontaine stage II (intermittent claudication) Physical assessment: Pulse status / Color-Coded Duplex Sonography / Ankle-Brachial Index / treadmill test / stepper exercise 2 minutes
- Primary Outcome Measures
Name Time Method 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
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
- Secondary Outcome Measures
Name Time Method 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
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)
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 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)
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
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
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
Trial Locations
- Locations (1)
University of Erlangen-Nuremberg (FAU), Department of Vascular Surgery
🇩🇪Erlangen, Bavaria, Germany