Calf Muscle Perfusion in Patients With Intermittent Claudication by 3D-reconstruction of MSOT (MSOT_IC_3D)

NCT05773534 | Unknown

• 1 other identifier: MSOT_IC_3D
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the proposed study is to define independent parameters for the diagnostic assessment of the perfusion situation of the calf muscle based on 3D-reconstruction of multispectral optoacoustic tomography (MSOT) in a cross-sectional collective of patients with PAD in Fontaine stage II and a healthy control group.

Conditions

Diagnostic Imaging; Peripheral Arterial Disease; Intermittent Claudication

Keywords

Peripheral Vascular Diseases; Peripheral Arterial Disease; Peripheral Artery Disease; PAD; Intermittent Claudication; Claudicatio intermittens; Color-Coded Duplex Sonography; CCDS; Ankle Brachial Index; ABI; Multispectral Optoacoustic Tomography; MSOT; Heel Raises; 6-minute walk test; 6MWT; Muscle Perfusion; Calf Muscle Perfusion; 3D; three-dimensional

Outcome Measures

Primary Outcomes (1)

• Optimal diagnostic MSOT thresholds

  Quantitative oxygenated hemoglobin signal in 3D-reconstruction (in arbitrary units). \[This target variable is collected non-invasively using MSOT\].

  single time point (1 day)

Secondary Outcomes (10)

• Difference between the corresponding 3D-reconstructed MSOT values before and after exercise

  single time point (1 day)

• Reperfusion profiles of hemoglobin-associated 3D-reconstructed MSOT parameters

  single time point (1 day)

• Correlation of acquired 3D-reconstructed MSOT parameters with the CCDS flow profiles and PSVs

  single time point (1 day)

• Correlation of acquired 3D-reconstructed MSOT parameters with the ABI

  single time point (1 day)

• Correlation of acquired 3D-reconstructed MSOT parameters with relative (until the first occurrence of pain) and absolute walking distance (until the first stopping due to pain) determined during the 6MWT

  single time point (1 day)

Study Arms (2)

healthy group

Multispectral Optoacoustic Tomography (MSOT) of the Musculus triceps surae of one leg in healthy volunteers Physical assessment: Pulse status / Color-Coded Duplex Sonography / Ankle-Brachial Index / 6-minute walk test (6MWT) / Continued heel raises for at least 30s

Diagnostic Test: MSOT

Patients with PAD in Fontaine stage II

Multispectral Optoacoustic Tomography (MSOT) of the Musculus triceps surae of the affected leg in PAD patients in Fontaine stage II (intermittent claudication) Physical assessment: Pulse status / Color-Coded Duplex Sonography / Ankle-Brachial Index / 6-minute walk test (6MWT) / Continued heel raises for at least 30s

Diagnostic Test: MSOT

Interventions

MSOT DIAGNOSTIC_TEST

Similar as the conventional sonography, the MSOT transducer head is placed on the skin of the examined person above the target organ. But instead of sound waves, energy is applied to the tissue via laser light, leading to constant changes of minimal expansions and contractions (thermoelastic expansion) of different tissue components or molecules. The same transducer head that releases the laser flashes can also detect the emitted ultrasound waves. In the newly configured device (Acuity Echo, iThera Medical GmbH, Munich, CE-certified), an extended spectrum of laser light can be used, enabling among others the derivation of values corresponding to hemoglobin and its oxygenation levels. As hemoglobin concentration and oxygenation status are markers for perfusion, MSOT-based imaging of these parameters could be a highly sensitive and reliable method to analyze muscle perfusion.

Also known as: multispectral optoacoustic tomograph

Patients with PAD in Fontaine stage II; healthy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Definition of the patient groups: * PAD in Fontaine stage IIa * PAD in Fontaine stage IIb Definition of the healthy control group : * Absence of PAD * Absence of diabetes mellitus * Absence of chronic renal insufficiency * No symptoms of intermittent claudication * ABI with values between 0.9 and 1.4 (screening examination before inclusion in the study) * Palpable foot pulses

You may qualify if:

• Patients with PAD in Fontaine stage II or Rutherford category 1-3 or healthy volunteers
• Adults (\>18 years) who are able to give their consent

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
• Ph.D. Student Niklas Holzwarth, Inteligent Medical Systems, German Cancer Research Center: collaborator

Study Sites (1)

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

Erlangen, Bavaria, 91054, Germany

RECRUITING

Related Publications (5)

• Aboyans V, Ricco JB, Bartelink MEL, Bjorck M, Brodmann M, Cohnert T, Collet JP, Czerny M, De Carlo M, Debus S, Espinola-Klein C, Kahan T, Kownator S, Mazzolai L, Naylor AR, Roffi M, Rother J, Sprynger M, Tendera M, Tepe G, Venermo M, Vlachopoulos C, Desormais I; ESC Scientific Document Group. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteriesEndorsed by: the European Stroke Organization (ESO)The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur Heart J. 2018 Mar 1;39(9):763-816. doi: 10.1093/eurheartj/ehx095. No abstract available.

  PMID: 28886620 BACKGROUND

• Lawall H, Huppert P, Espinola-Klein C, Zemmrich CS, Ruemenapf G. German guideline on the diagnosis and treatment of peripheral artery disease - a comprehensive update 2016. Vasa. 2017 Mar;46(2):79-86. doi: 10.1024/0301-1526/a000603. Epub 2017 Jan 27.

  PMID: 28128018 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Related Links

• 4\. Lawall, H., P. Huppert, and G. Rümenapf. Periphere arterielle Verschlusskrankheit (PAVK), Diagnostik, Therapie und Nachsorge. \[S3 guideline\] 2015 31.03.2021\];

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Ulrich Rother, PD Dr. med.

CONTACT

+4991318542028; ulrich.rother@uk-erlangen.de

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: March 6, 2023
• First Posted: March 17, 2023
• Study Start: February 27, 2022
• Primary Completion: March 31, 2023
• Study Completion: May 31, 2023
• Last Updated: March 17, 2023

Record last verified: 2023-03

Locations

DE (1)