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

NCT06391346 | Recruiting

• 1 other identifier: MSOT-gluteal
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Difference between the corresponding MSOT values before and after exercis

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

• Reperfusion profiles for hemoglobin-associated parameters

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

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

  single time point

• Correlation of acquired MSOT parameters with the ABI

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

• Correlation of acquired MSOT parameters with threadmill test

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

Study Arms (1)

Patient

EXPERIMENTAL

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

Interventions

MSOT DIAGNOSTIC_TEST

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

Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with gluteal claudication in Fontaine stage II and corresponding stenosis (common iliac artery, internal iliac artery or distal aorta)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ulrich Rother: lead

Study Sites (1)

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

Erlangen, Bavaria, 91054, Germany

RECRUITING

Related Publications (9)

• 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.

  PMID: 26625226 RESULT

• 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.

  PMID: 4885945 RESULT

• 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.

  PMID: 33553329 RESULT

• 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.

  PMID: 28938901 RESULT

• 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.

  PMID: 12668524 RESULT

• 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.

  PMID: 37600964 RESULT

• 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.

  PMID: 28413177 RESULT

• 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.

  PMID: 16678694 RESULT

• 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.

  PMID: 23340534 RESULT

MeSH Terms

Conditions

Peripheral Vascular Diseases; Peripheral Arterial Disease; Intermittent Claudication

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr. med.

Model Details: Perfusion parameters from MSOT would be measured on patients with gluteal claudication in Fontain stage 2 before and after the revascularisation.

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: April 30, 2024
• Study Start: June 23, 2023
• Primary Completion: March 14, 2024
• Study Completion: April 1, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)