An observational study in Peripheral Vascular Diseases and Peripheral Arterial Disease, sponsored by University Hospital Erlangen. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-21.
Sponsored by University Hospital Erlangen · 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.
Functional imaging diagnostics is becoming increasingly important due to the steadily growing knowledge of physiological processes in many diseases. Also in peripheral arterial occlusive disease (PAD), new insights into the pathomechanism of the disease are continuously being gained. This also increases the need for new non-invasive imaging methods that are able to visualize the functional level of the disease progression and thus make it possible to diagnose it at an early stage.
Recent studies indicate that it may be feasible to use multispectral optoacoustic tomography (MSOT) to visualize hemodynamics as well as the fibrotic muscle remodeling process in PAD. For a better understanding of the distribution pattern , the exploration of a 3D technique is a next necessary step in imaging. This may show a possible existing heterogeneity of these molecules.
Holzwarth et al. were already able to gain knowledge about the 3D reconstruction from 2D photoacoustic image slices using an optical pattern and the method's feasibility using phantoms as well as in-vivo measurements of the forearm in healthy volunteers.
The aim of this exploratory pilot project is to bring these previous findings together and to image muscle perfusion of the lower extremity in three dimensions using the MSOT method and to verify its feasibility. The advantage of 3D imaging is, beyond the anatomical topography of the muscle, to map a three-dimensional representation of the perfusion situation based on muscle oxygenation.
For this purpose, six patients of different symptomatic PAD stages and a healthy control of two volunteers will be included and examined by means of longitudinal MSOT scans in the area of the gastrocnemius muscle. To evaluate the current stage of the disease or to exclude relevant PAD in the healthy control population, non-invasive examination measures commonly used in routine diagnostics of PAD will be applied. In addition to the relevant risk factors/adjacent diseases and the current medication intake, these include the recording of the ankle-brachial index (ABI), color-coded duplex sonographic vascular imaging (CCDS) and a treadmill examination.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's enrollment of 9 is below the median of 190 across 410 observational studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →University Hospital Erlangen is the lead sponsor of 27 studies on the registry; 3 are open to participants now.
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Patients with PAD IIa/IIb/III/IV according to Fontaine who come in for a routine presentation of the the vascular surgery consultation hours.
Healthy volunteers with
Exclusion Criteria:
Multispectral Optoacoustic Tomography (MSOT) and B-Mode Ultrasound of the Musculus gastrocnemius of the affected leg in PAD patients or one leg in healthy volunteers (total 1 site) Physical assessment: Color-Coded Duplex Sonography/treadmill examination to determine actual walking distance/Ankle-Brachial-Index/defined walking distance of 150 meters under medical supervision
Device: Multispectral Optoacoustic Tomography (MSOT)
non-invasive transcutaneous imaging of subcellular muscle components
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
Time frame: single time point (1 day)
Acquisition of the quantitative hemoglobin signal (oxygenated/deoxygenated)
This Outcome is measured non-invasively by MSOT, the single wavelengths are spectrally unmixed
Time frame: single time point (1 day)
Acquisition of the quantitative fibrosis signals (collagen/lipid)
This Outcome is measured non-invasively by MSOT, the single wavelengths are spectrally unmixed
Time frame: single time point (1 day)
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.
Time frame: single time point (1 day)
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.
Time frame: single time point (1 day)
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
Time frame: single time point (1 day)
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
Time frame: single time point (1 day)
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
Time frame: single time point (1 day)
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
Time frame: single time point (1 day)
Acquisition of the PAD stage according to Fontaine and Rutherford
This Outcome is acquired by actual recommendation from national and international guidelines
Time frame: single time point (1 day)
Recording of relevant patient data from the patient's file
Preexisting disorders, previous performed operations on vessels, current medication, radiological TransAtlantic InterSociety Consensus classification
Time frame: single time point (1 day)
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University Hospital Erlangen