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

Evaluation of Gluteal Muscle Perfusion in Patients With Intermittent Gluteal Claudication by Non-invasive Multispectral Optoacoustic Tomography With Pre-post Study Design

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.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication; Gluteal Claudication
• Intervention / Treatment: Diagnostic test: MSOT

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Recruiting
      • University of Erlangen-Nuremberg (FAU), Department of Vascular Surgery
      • Contact: Ulrich Rother, Dr. med.; Phone Number: +4991318542028; Email: ulrich.rother@uk-erlangen.de
      • Contact: Werner Lang, Prof. Dr. med.; Phone Number: +4991318532968; Email: werner.lang@uk-erlangen.de
      • Sub-Investigator: Yi Li, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient; 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	Diagnostic test: MSOT; Non-invasive transcutaneous imaging of muscle components via infrared and near-infrared laser pulses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	twice (before and after the intervention, up to two weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	single time point
Correlation of acquired MSOT parameters with the ABI	Hemoglobin-associated parameters derived by transcutaneous MSOT correlated with the ABI	twice (before and after the intervention, up to two weeks)
Correlation of acquired MSOT parameters with threadmill test	Hemoglobin-associated MSOT parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT correlated with Threadmill test	twice (before and after the intervention, up to two weeks)
Correlation of acquired MSOT parameters with subjectively perceived maximum walking distance in everyday life	hemoglobin-associated MSOT parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT correlated with the 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)	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)	twice (before and after the intervention, up to two weeks)
Correlation of acquired MSOT parameters with the TASC-classification (angiography)	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)	twice (before and after the intervention, up to two weeks)
Confounder analysis	Correlation of all collected parameters (anamnestic, demographic, physiological) with regard to their characteristics as basic confounders for the MSOT technique	twice (before and after the intervention, up to two weeks)

Collaborators and Investigators

• Sponsor: Ulrich Rother

Publications and helpful links

General Publications

• Lawall H, Diehm C, Hoffmann U, Reinecke H. [Update PAVK: Epidemiology, comorbidity and prognosis of peripheral arterial obstructive disease]. Dtsch Med Wochenschr. 2015 Dec;140(24):1798-802. doi: 10.1055/s-0041-107064. Epub 2015 Dec 1. German.
• Alpert JS, Larsen OA, Lassen NA. Exercise and intermittent claudication. Blood flow in the calf muscle during walking studied by the xenon-133 clearance method. Circulation. 1969 Mar;39(3):353-9. doi: 10.1161/01.cir.39.3.353. No abstract available.
• Karlas A, Masthoff M, Kallmayer M, Helfen A, Bariotakis M, Fasoula NA, Schafers M, Seidensticker M, Eckstein HH, Ntziachristos V, Wildgruber M. Multispectral optoacoustic tomography of peripheral arterial disease based on muscle hemoglobin gradients-a pilot clinical study. Ann Transl Med. 2021 Jan;9(1):36. doi: 10.21037/atm-20-3321.
• Larsen ASF, Reiersen AT, Jacobsen MB, Klow NE, Nordanstig J, Morgan M, Wesche J. Validation of the Vascular quality of life questionnaire - 6 for clinical use in patients with lower limb peripheral arterial disease. Health Qual Life Outcomes. 2017 Sep 22;15(1):184. doi: 10.1186/s12955-017-0760-3.
• Abraham P, Picquet J, Vielle B, Sigaudo-Roussel D, Paisant-Thouveny F, Enon B, Saumet JL. Transcutaneous oxygen pressure measurements on the buttocks during exercise to detect proximal arterial ischemia: comparison with arteriography. Circulation. 2003 Apr 15;107(14):1896-900. doi: 10.1161/01.CIR.0000060500.60646.E0. Epub 2003 Mar 31.
• Assi H, Cao R, Castelino M, Cox B, Gilbert FJ, Grohl J, Gurusamy K, Hacker L, Ivory AM, Joseph J, Knieling F, Leahy MJ, Lilaj L, Manohar S, Meglinski I, Moran C, Murray A, Oraevsky AA, Pagel MD, Pramanik M, Raymond J, Singh MKA, Vogt WC, Wang L, Yang S, Members Of Ipasc, Bohndiek SE. A review of a strategic roadmapping exercise to advance clinical translation of photoacoustic imaging: From current barriers to future adoption. Photoacoustics. 2023 Aug 2;32:100539. doi: 10.1016/j.pacs.2023.100539. eCollection 2023 Aug.
• Audonnet M, Signolet I, Colas-Ribas C, Ammi M, Abraham P, Henni S. Exercise Transcutaneous Oximetry of the Buttocks - External Validation With Computed Tomography Angiography. Circ J. 2017 Jul 25;81(8):1123-1128. doi: 10.1253/circj.CJ-16-1316. Epub 2017 Apr 13.
• Batt M, Baque J, Bouillanne PJ, Hassen-Khodja R, Haudebourg P, Thevenin B. Percutaneous angioplasty of the superior gluteal artery for buttock claudication: a report of seven cases and literature review. J Vasc Surg. 2006 May;43(5):987-91. doi: 10.1016/j.jvs.2006.01.024.
• Gernigon M, Marchand J, Ouedraogo N, Leftheriotis G, Piquet JM, Abraham P. Proximal ischemia is a frequent cause of exercise-induced pain in patients with a normal ankle to brachial index at rest. Pain Physician. 2013 Jan;16(1):57-64.

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2023
• Primary Completion (Actual): March 14, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: February 20, 2024
• First Submitted That Met QC Criteria: April 28, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 28, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: PAD; Peripheral Artery Disease; Peripheral Arterial Disease; Multispectral Optoacoustic Tomography; MSOT; Peripheral Vascular Diseases; Gluteal claudication; Buttock claudication
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication
• Other Study ID Numbers: MSOT-gluteal

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No