Muscle Perfusion in Patients With PAD by Non-invasive MSOT

NCT ID: NCT04641091

Last Updated: 2022-03-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 220 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-13
• Study Completion Date: 2022-02-18

Brief Summary

The aim of the proposed study is to define an independent parameter for the diagnostic assessment of the perfusion situation of the calf muscle based on Multispectral Optoacoustic Tomography (MSOT) in a cross-sectional collective of healthy volunteers and patients with PAD. The gold standard is a previously performed angiography of the pelvic and femoral vessels based on routine diagnostics, this Imaging is not mandatory for healthy Control group (study group 1). An independent validation group (study group 2) will validate the results found in study group 1.

Detailed Description

Peripheral arterial occlusive disease (PAD) is one of the most common diseases of the elderly with an overall prevalence of about 3-10%. As life expectancy increases, new treatment concepts and new diagnostic procedures are needed. In addition to the possibility of endovascular treatment and open surgery, in some cases there is also the possibility of a conservative therapeutic approach, e.g. with medication.

To date, the only independent non-invasive validation of these treatment options is the measurement of macrocirculation in the form of Color-Coded Vascular Duplex Sonography (CCDS), the Ankle Brachial Index (ABI) or the measurement of walking distance. The S3 guideline for diagnosis, therapy and medical aftercare of PAD published 2015 by the DGA (Deutsche Gesellschaft für Angiologie und Gefäßmedizin [German Society for Angiology and Vascular Medicine]) recommends aftercare in the sense of clinical examinations, especially for patients after vascular surgery. For the validation measures already mentioned, however, there are not infrequent patient groups for which these methods provide only insufficient or unusable results (diabetes mellitus, terminal renal failure). In these cases, independent verification of the success of the therapy performed would have to be performed using angiography (digital subtraction angiography, CT angiography or MR angiography). However, this is not routinely performed in the respective patient populations due to the associated risks (including radiation exposure, contrast agent administration, invasiveness).

Multispectral Optoacoustic Tomography (MSOT) now provides a new non-invasive diagnostic tool that may be able to fill this diagnostic gap.

The aim of this cross-sectional study is to define an independent parameter using the MSOT method, which allows a statement about the current perfusion situation of the lower extremity and correlates with the angiography, which is considered the gold standard. For this purpose, patients of different PAD stages, who already underwent routinely angiographies in advance, will be included. In addition, a control group of healthy volunteers (prior angiography not obligatory) will be examined.

Conditions

Peripheral Vascular Disease; Peripheral Arterial Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Study group 1

Multispectral Optoacoustic Tomography (MSOT) and B-Mode Ultrasound of the Musculus triceps surae 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

Multispectral Optoacustic Tomography (MSOT)

Intervention Type: DEVICE

non-invasive transcutaneous imaging of subcellular muscle components

Study group 2

Multispectral Optoacoustic Tomography (MSOT) and B-Mode Ultrasound of the Musculus triceps surae 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

Multispectral Optoacustic Tomography (MSOT)

Intervention Type: DEVICE

non-invasive transcutaneous imaging of subcellular muscle components

Interventions

Multispectral Optoacustic Tomography (MSOT)

non-invasive transcutaneous imaging of subcellular muscle components

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients with manifest PAD stages II - IV according to Fontaine or category 1-6 according to Rutherford
• Adult (>18 years) persons who are able to give their consent
• Patients in whom angiography has been performed as part of routine diagnostics (independent of the study) or in accordance with current guidelines, or has been indicated and the patients has given consent

Exclusion Criteria

• Patients with PAD stage I according to Fontaine or category 0 according to Rutherford
• Underage persons
• Missing consent form
• Patients with manifest PAD in whom angiography is not indicated
• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Department of Medicine 1 University Hospital Erlangen, Prof. Dr. Maximilian J. Waldner

UNKNOWN

Sponsor Role: collaborator

University Hospital Erlangen

OTHER

Sponsor Role: lead

Responsible Party

Ulrich Rother

PD Dr. med.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Erlangen, Vascular Surgery

Erlangen, , Germany

Countries

Germany

References

Lange S, Diehm C, Darius H, Haberl R, Allenberg JR, Pittrow D, Schuster A, von Stritzky B, Tepohl G, Trampisch HJ. High prevalence of peripheral arterial disease and low treatment rates in elderly primary care patients with diabetes. Exp Clin Endocrinol Diabetes. 2004 Nov;112(10):566-73. doi: 10.1055/s-2004-830408.

Reference Type: BACKGROUND

PMID: 15578331 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 4885945 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MSOT_PAD

Identifier Type: -

Identifier Source: org_study_id