Muscle Perfusion in Patients With PAD by Non-invasive MSOT

NCT04641091 | Completed

• 1 other identifier: MSOT_PAD
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Vascular Disease; Peripheral Arterial Disease

Keywords

Peripheral Vascular Disease; Peripheral Arterial Disease; Multispectral Optoacoustic Tomography; Revascularization; Claudicatio intermittens; Critical limb ischemia; MSOT; CLI; PAD; Angiography; Color-Coded Duplex Sonography; CCDS

Outcome Measures

Primary Outcomes (1)

• Derivation of optimal diagnostic MSOT thresholds for hemoglobin

  Derivation of optimal diagnostic MSOT thresholds for hemoglobin through correlation with TASC classification for angiographic imaging as references for relevant stenosis/ occlusion in patients with PAD

  single time point (1 day)

Secondary Outcomes (9)

• Muscular oxygenated/deoxygenated/total hemoglobin and the MSOT-values at a wavelength of 800nm before and after gait exposure

  single time point (1 day)

• Correlation of oxygenated/deoxygenated/total hemoglobin content and MSOT-values at a wavelength of 800 nm with the TASC-classification (angiography)

  single time point (1 day)

• Difference between oxygenated/deoxygenated hemoglobin before and after gait exposure

  single time point (1 day)

• Correlation of difference between oxygenated/deoxygenated hemoglobin with the TASC-classification (angiography)

  single time point (1 day)

• Muscular quantitative lipid/collagen signal fraction and the MSOT-values at a wavelength of 930 and 1064 nm

  single time point (1 day)

Study Arms (2)

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

Device: Multispectral Optoacustic Tomography (MSOT)

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

Device: Multispectral Optoacustic Tomography (MSOT)

Interventions

Multispectral Optoacustic Tomography (MSOT) DEVICE

non-invasive transcutaneous imaging of subcellular muscle components

Study group 1; Study group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with * PAD IIa with indication for angiography * PAD IIb with indication for angiography * PAD III with indication for angiography * PAD IV with indication for angiography who come in for a routine presentation of the vascular surgery consultation hours. And healthy volunteers: * No PAD previously known * No diabetes mellitus previously known * No chronic renal insufficiency previously known * No symptoms in the sense of a Claudicatio intermitten * ABI with normal value who are recruted by clinic notices.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Erlangen: lead
• Department of Medicine 1 University Hospital Erlangen, Prof. Dr. Maximilian J. Waldner: collaborator

Study Sites (1)

University of Erlangen, Vascular Surgery

Erlangen, 91054, Germany

Location

Related Publications (2)

• 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.

  PMID: 15578331 BACKGROUND

• 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.

  PMID: 4885945 BACKGROUND

MeSH Terms

Conditions

Peripheral Vascular Diseases; Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: November 23, 2020
• Study Start: November 13, 2020
• Primary Completion: October 1, 2021
• Study Completion: February 18, 2022
• Last Updated: March 7, 2022

Record last verified: 2022-02

Locations

DE (1)