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

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06391346
• Other study ID #: MSOT-gluteal
• Status: Recruiting
• Phase: N/A
• Start date: June 23, 2023
• Est. completion date: April 2024

Study information

• Verified date: April 2024
• Source: University Hospital Erlangen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 2024
• Est. primary completion date: March 14, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Diagnostic Test:
• MSOT
Non-invasive transcutaneous imaging of muscle components via infrared and near-infrared laser pulses

Locations

Country	Name	City	State
Germany	University of Erlangen-Nuremberg (FAU), Department of Vascular Surgery	Erlangen	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Ulrich Rother

Country where clinical trial is conducted

Germany, 

References & Publications (9)

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 Ap — View Citation

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. — View Citation

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, M — View Citation

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 A — View Citation

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. — View Citation

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. — View 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 pil — View 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; — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)