Clinical trial NCT05773534: Calf Muscle Perfusion in Patients With Intermittent Claudication by 3D-reconstruction of MSOT (MSOT_IC_3D)
Official title: Cross-sectional Study of Calf Muscle Perfusion Via 3D Reconstruction of Multispectral Optoacoustic Tomography in Patients With Peripheral Arterial Disease After Exercise.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: University Hospital Erlangen
Sponsor class: OTHER
Collaborators: name: Ph.D. Student Niklas Holzwarth, Inteligent Medical Systems, German Cancer Research Center
First posted: 2023-03-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.

Detailed description: This is a monocentric, prospective cross-sectional study which aims to compare the 3D-reconstructed optoacoustic signals in calf muscle after a exercise in patients with PAD in Fontaine stage II and a healthy control group in order to define MSOT thresholds. MSOT data will be correlated with CCDS, ABI, maximum walking distance in 6MWT, 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 intermittent claudication will be recruited during the consulting hours of the Department of Vascular Surgery, University Hospital Erlangen. Healthy volunteers will be acquired via posters in the clinic. 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 3D-reconstructed parameters will be recorded by means of longitudinal MSOT scans before and after a heel raise exercise until the occurrence of claudication pain in the calf muscle. For patients with PAD, the more affected leg is examined. In healthy volunteers, either leg is examined. ABI would be measured before and after 6MWT. 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 (if available, independently from this study and the interval between MSOT measurement being lesser than 12 months). The complete study including the validation of the data by an independent study group is expected to be finished within one year.

Eligibility criteria: Inclusion Criteria:

* 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

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: single time point (1 day)
Secondary outcomes:
measure: Difference between the corresponding 3D-reconstructed MSOT values before and after exercise
timeFrame: single time point (1 day)
measure: Reperfusion profiles of hemoglobin-associated 3D-reconstructed MSOT parameters
timeFrame: single time point (1 day)
measure: Correlation of acquired 3D-reconstructed MSOT parameters with the CCDS flow profiles and PSVs
timeFrame: single time point (1 day)
measure: Correlation of acquired 3D-reconstructed MSOT parameters with the ABI
timeFrame: single time point (1 day)
measure: 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
timeFrame: single time point (1 day)
measure: Correlation of acquired 3D-reconstructed MSOT parameters with maximum walking distance in the 6MWT
timeFrame: single time point (1 day)
measure: Correlation of acquired 3D-reconstructed MSOT parameters with the subjectively perceived maximum walking distance in everyday life
timeFrame: single time point (1 day)
measure: Correlation of acquired 3D-reconstructed MSOT parameters with the perceived PAD-specific quality of life (VASCUQOL-6 questionnaire)
timeFrame: single time point (1 day)
measure: Correlation of the acquired 3D-reconstructed MSOT parameters with the TASC-classification (angiography)
timeFrame: single time point (1 day)
measure: Confounder analysis
timeFrame: single time point (1 day)
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University of Erlangen-Nuremberg (FAU), Department of Vascular Surgery
state: Bavaria
Study officials:
References:
citation: 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.
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citation: 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.
citation: 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.