Investigation of the Perfusion of Gluteal Muscle in Patients With Intermittent Gluteal Claudication by Non-invasive MSOT

Ulrich Rother20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Peripheral Vascular Diseases Peripheral Arterial Disease Intermittent Claudication Gluteal Claudication

Interventions

MSOTDIAGNOSTIC_TEST

Non-invasive transcutaneous imaging of muscle components via infrared and near-infrared laser pulses

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Erlangen-Nuremberg (FAU), Department of Vascular Surgery

Erlangen, Bavaria, Germany

RECRUITING

Outcomes

Primary Outcomes

Optimal diagnostic MSOT thresholds

optimal diagnostic threshold for hemoglobin-associated MSOT parameters in gluteal muscle tissue in patients with intermittent claudication before and after exercise

Time frame: twice (before and after the intervention, up to two weeks)

Improvement of the MSOT parameters after the revascularisation

Change of hemoglobin-associated MSOT parameters in gluteal muscle tissue in patients with intermittent claudication before and after exercise after the revascularisation

Time frame: twice (before and after the intervention, up to two weeks)

Secondary Outcomes

Difference between the corresponding MSOT values before and after exercis

Difference of the values before and after exercise for hemoglobin-associated parameters derived by transcutaneous MSOT in patients with gluteal claudication

Time frame: twice (before and after the intervention, up to two weeks)

Reperfusion profiles for hemoglobin-associated parameters

Curves of hemoglobin-associated MSOT parameters in the first ten minutes after exercise

Time frame: twice (before and after the intervention, up to two weeks)

Correlation of acquired MSOT parameters with the CCDS flow profile and PSV

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

Time frame: single time point

Correlation of acquired MSOT parameters with the ABI

Hemoglobin-associated parameters derived by transcutaneous MSOT correlated with the ABI

Data from ClinicalTrials.gov

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