Clinical trial NCT06391346: Investigation of the Perfusion of Gluteal Muscle in Patients With Intermittent Gluteal Claudication by Non-invasive MSOT
Official title: Evaluation of Gluteal Muscle Perfusion in Patients With Intermittent Gluteal Claudication by Non-invasive Multispectral Optoacoustic Tomography With Pre-post Study Design
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Vascular Diseases
Peripheral Arterial Disease
Intermittent Claudication
Gluteal Claudication
Keywords: Peripheral Vascular Diseases
Peripheral Arterial Disease
Peripheral Artery Disease
PAD
Gluteal claudication
Buttock claudication
MSOT
Multispectral Optoacoustic Tomography
Lead sponsor: University Hospital Erlangen
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Perfusion parameters from MSOT would be measured on patients with gluteal claudication in Fontain stage 2 before and after the revascularisation.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Optimal diagnostic MSOT thresholds
timeFrame: twice (before and after the intervention, up to two weeks)
measure: Improvement of the MSOT parameters after the revascularisation
timeFrame: twice (before and after the intervention, up to two weeks)
Secondary outcomes:
measure: Difference between the corresponding MSOT values before and after exercis
timeFrame: twice (before and after the intervention, up to two weeks)
measure: Reperfusion profiles for hemoglobin-associated parameters
timeFrame: twice (before and after the intervention, up to two weeks)
measure: Correlation of acquired MSOT parameters with the CCDS flow profile and PSV
timeFrame: single time point
measure: Correlation of acquired MSOT parameters with the ABI
timeFrame: twice (before and after the intervention, up to two weeks)
measure: Correlation of acquired MSOT parameters with threadmill test
timeFrame: twice (before and after the intervention, up to two weeks)
measure: Correlation of acquired MSOT parameters with subjectively perceived maximum walking distance in everyday life
timeFrame: twice (before and after the intervention)
measure: Correlation of acquired MSOT parameters with the perceived PAD-specific quality of life (VASCUQOL-6 questionnaire)
timeFrame: twice (before and after the intervention, up to two weeks)
measure: Correlation of acquired MSOT parameters with the TASC-classification (angiography)
timeFrame: twice (before and after the intervention, up to two weeks)
measure: Confounder analysis
timeFrame: twice (before and after the intervention, up to two weeks)
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University of Erlangen-Nuremberg (FAU), Department of Vascular Surgery
state: Bavaria
Study officials:
References:
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