Peripheral Arterial Disease Clinical Trial
Official title:
Cross-sectional Study of Calf Muscle Perfusion Via 3D Reconstruction of Multispectral Optoacoustic Tomography in Patients With Peripheral Arterial Disease After Exercise.
NCT number | NCT05773534 |
Other study ID # | MSOT_IC_3D |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | February 27, 2022 |
Est. completion date | May 31, 2023 |
The aim of the proposed study is to define independent parameters for the diagnostic assessment of the perfusion situation of the calf muscle based on 3D-reconstruction of multispectral optoacoustic tomography (MSOT) in a cross-sectional collective of patients with PAD in Fontaine stage II and a healthy control group.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | May 31, 2023 |
Est. primary completion date | March 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients with PAD in Fontaine stage II or Rutherford category 1-3 or healthy volunteers - Adults (>18 years) who are able to give their consent 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 |
Country | Name | City | State |
---|---|---|---|
Germany | University of Erlangen-Nuremberg (FAU), Department of Vascular Surgery | Erlangen | Bavaria |
Lead Sponsor | Collaborator |
---|---|
Ulrich Rother | Ph.D. Student Niklas Holzwarth, Inteligent Medical Systems, German Cancer Research Center |
Germany,
Aboyans V, Ricco JB, Bartelink MEL, Bjorck M, Brodmann M, Cohnert T, Collet JP, Czerny M, De Carlo M, Debus S, Espinola-Klein C, Kahan T, Kownator S, Mazzolai L, Naylor AR, Roffi M, Rother J, Sprynger M, Tendera M, Tepe G, Venermo M, Vlachopoulos C, Desormais I; ESC Scientific Document Group. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteriesEndorsed by: the European Stroke Organization (ESO)The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur Heart J. 2018 Mar 1;39(9):763-816. doi: 10.1093/eurheartj/ehx095. No abstract available. — 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 pilot clinical study. Ann Transl Med. 2021 Jan;9(1):36. doi: 10.21037/atm-20-3321. — 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;15(1):184. doi: 10.1186/s12955-017-0760-3. — 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
Lawall H, Huppert P, Espinola-Klein C, Zemmrich CS, Ruemenapf G. German guideline on the diagnosis and treatment of peripheral artery disease - a comprehensive update 2016. Vasa. 2017 Mar;46(2):79-86. doi: 10.1024/0301-1526/a000603. Epub 2017 Jan 27. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Optimal diagnostic MSOT thresholds | Quantitative oxygenated hemoglobin signal in 3D-reconstruction (in arbitrary units).
[This target variable is collected non-invasively using MSOT]. |
single time point (1 day) | |
Secondary | Difference between the corresponding 3D-reconstructed MSOT values before and after exercise | Difference of the values before and after exercise for hemoglobin-associated parameters derived by transcutaneous MSOT inpatients in intermittent claudication stage | single time point (1 day) | |
Secondary | Reperfusion profiles of hemoglobin-associated 3D-reconstructed MSOT parameters | i.e. the curves of hemoglobin-associated MSOT parameters in the first ten minutes after exercise | single time point (1 day) | |
Secondary | Correlation of acquired 3D-reconstructed MSOT parameters with the CCDS flow profiles and PSVs | hemoglobin-associated MSOT parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT in patients with PAD in Fontaine stage II correlated with the flow profiles and PSVs of A. femoralis communis and A. poplitea determined by CCDS | single time point (1 day) | |
Secondary | Correlation of acquired 3D-reconstructed MSOT parameters with the ABI | hemoglobin-associated MSOT parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT correlated with the ABI measurements | single time point (1 day) | |
Secondary | Correlation of acquired 3D-reconstructed MSOT parameters with relative (until the first occurrence of pain) and absolute walking distance (until the first stopping due to pain) determined during the 6MWT | hemoglobin-associated MSOT parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT correlated with relative (until the first occurrence of pain) and absolute walking distance (until the first stopping due to pain) | single time point (1 day) | |
Secondary | Correlation of acquired 3D-reconstructed MSOT parameters with maximum walking distance in the 6MWT | hemoglobin-associated, 3D-reconstructed MSOT parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT correlated with the maximum walking distance in the 6MWT | single time point (1 day) | |
Secondary | Correlation of acquired 3D-reconstructed MSOT parameters with the subjectively perceived maximum walking distance in everyday life | hemoglobin-associated, 3D-reconstructed MSOT parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT correlated with the subjectively perceived maximum walking distance in everyday life | single time point (1 day) | |
Secondary | Correlation of acquired 3D-reconstructed MSOT parameters with the perceived PAD-specific quality of life (VASCUQOL-6 questionnaire) | hemoglobin-associated, 3D-reconstructed MSOT parameters (units: arbitrary units (a.u.)) derived by transcutaneous MSOT correlated with the perceived PAD-specific quality of life (VASCUQOL-6 questionnaire) | single time point (1 day) | |
Secondary | Correlation of the acquired 3D-reconstructed MSOT parameters with the TASC-classification (angiography) | hemoglobin-associated, 3D-reconstructed 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) | single time point (1 day) | |
Secondary | Confounder analysis | • Correlation of all collected parameters (anamnestic, demographic, physiological) with regard to their characteristics as basic confounders for the MSOT technique | single time point (1 day) |
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