Peripheral Arterial Disease Clinical Trial
Official title:
Pilot Study of Topographic Imaging of the Gastrocnemius Muscle in Patients With PAD Using Non-invasive Multispectral Optoacoustic Tomography (MSOT) as a 3D Reconstruction Based on Longitudinal 2D Measurements
Verified date | February 2022 |
Source | University Hospital Erlangen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The aim of this explorative pilot study is to present muscle perfusion of the lower extremity in patients with PAD using the Multispectral Optoacoustic Tomography (MSOT) method to build a 3D reconstruction of the calf muscle. This study aims to show the feasibility of 3D reconstruction of this non-invasive method. Advantages in diagnostics for patients with PAD and three-dimensional tomography representation of the perfusion situation based on muscle oxygenation will be evaluated.
Status | Active, not recruiting |
Enrollment | 9 |
Est. completion date | July 31, 2022 |
Est. primary completion date | January 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients with manifest PAD stages II-IV according to Fontaine or healthy volunteers - Adult (>18 years) persons who are able to give their consent Exclusion Criteria: - Patients with PAD stage I according to Fontaine - Healthy volunteers with pre-existing diabetes mellitus, chronic renal failure, or abnormal ABI - Underage persons - Missing consent form - Exclusion due to safety concerns of the study physician (patient with a physical, mental or psychiatric illness which, in the opinion of the study physician, would compromise the safety of the patient or the quality of the data and thus make the patient an unsuitable candidate for the study) |
Country | Name | City | State |
---|---|---|---|
Germany | University of Erlangen, Vascular Surgery | Erlangen |
Lead Sponsor | Collaborator |
---|---|
University Hospital Erlangen | Department of Pediatrics and Adolescent Medicine, University Hospital Erlangen, Erlangen, Germany, Division of Computer Assisted Medical Interventions, German Cancer Research Center, Heidelberg, Germany |
Germany,
Holzwarth N, Schellenberg M, Gröhl J, Dreher K, Nölke JH, Seitel A, Tizabi MD, Müller-Stich BP, Maier-Hein L. Tattoo tomography: Freehand 3D photoacoustic image reconstruction with an optical pattern. Int J Comput Assist Radiol Surg. 2021 Jul;16(7):1101-1110. doi: 10.1007/s11548-021-02399-w. Epub 2021 May 16. — View Citation
Karlas A, Kallmayer M, Fasoula NA, Liapis E, Bariotakis M, Krönke M, Anastasopoulou M, Reber J, Eckstein HH, Ntziachristos V. Multispectral optoacoustic tomography of muscle perfusion and oxygenation under arterial and venous occlusion: A human pilot study. J Biophotonics. 2020 Jun;13(6):e201960169. doi: 10.1002/jbio.201960169. Epub 2020 Mar 25. — View Citation
Signorelli SS, Vanella L, Abraham NG, Scuto S, Marino E, Rocic P. Pathophysiology of chronic peripheral ischemia: new perspectives. Ther Adv Chronic Dis. 2020 Feb 5;11:2040622319894466. doi: 10.1177/2040622319894466. eCollection 2020. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MSOT topogram showing MSOT parameters from 660 up to 1100 nm of the gastrocnemius muscle | MSOT topogram using 3D reconstruction based on longitudinal 2D scans trough an optical pattern showing MSOT parameters from 660 up to 1100 nm of the gastrocnemius muscle | single time point (1 day) | |
Secondary | Acquisition of the quantitative hemoglobin signal (oxygenated/deoxygenated) | This Outcome is measured non-invasively by MSOT, the single wavelengths are spectrally unmixed | single time point (1 day) | |
Secondary | Acquisition of the quantitative fibrosis signals (collagen/lipid) | This Outcome is measured non-invasively by MSOT, the single wavelengths are spectrally unmixed | single time point (1 day) | |
Secondary | 3D reconstruction of the longitudinal measurements using two different pattern designs | This Outcome is measured non-invasively by MSOT. A foil imprinted with an "N" is applied and fixed over the calf muscle. Three longitudinal 2D measurements are made or repeated until a promising result is obtained. The same procedure is repeated with a foil imprinted with a trident. | single time point (1 day) | |
Secondary | Acquisition of static 2D MSOT measurements before and after gait exposure | This Outcome is measured non-invasively by MSOT. An initial measurement is taken at rest. Subsequently, the patient will complete a defined walking distance of 150 meters under medical supervision. Afterwards, the medial head of the gastrocnemius muscle is measured again. | single time point (1 day) | |
Secondary | Validation of the accuracy of the MSOT 3D reconstruction using an overlay from MRA | This Outcome is only realized in participants who received an magnetic resonance angiography regardless of study participation | single time point (1 day) | |
Secondary | Acquisition of the flow profile of the common femoral artery and popliteal artery using CCDS | This Outcome is measured non-invasively by standardized vascular sonography | single time point (1 day) | |
Secondary | Acquisition of the Ankle-Brachial-Index | This Outcome is measured non-invasively by standardized clinical assessment according to the according to the recommendation from the S3 guideline for PAD of the German Association for Angiology ("Deutsche Gesellschaft für Angiologie") dated November 30, 2015 | single time point (1 day) | |
Secondary | Acquisition of the current walking distance standardized by treadmill examination | This Outcome is measured by a standardized treadmill examination (excluding PAD patients in chronic critical stage III or IV according to Fontaine) ideally with 3km/h and 12% incline | single time point (1 day) | |
Secondary | Acquisition of the PAD stage according to Fontaine and Rutherford | This Outcome is acquired by actual recommendation from national and international guidelines | single time point (1 day) | |
Secondary | Recording of relevant patient data from the patient's file | Preexisting disorders, previous performed operations on vessels, current medication, radiological TransAtlantic InterSociety Consensus classification | single time point (1 day) |
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