Cross-sectional Study of Muscle Perfusion in Patients With PAD by Non-invasive Multispectral Optoacoustic Tomography
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Vascular Disease
- Sponsor
- University Hospital Erlangen
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- Derivation of optimal diagnostic MSOT thresholds for hemoglobin
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Ulrich Rother
PD Dr. med.
University Hospital Erlangen
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Derivation of optimal diagnostic MSOT thresholds for hemoglobin
Time Frame: single time point (1 day)
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
Secondary Outcomes
- 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))
- Muscular quantitative lipid/collagen signal fraction and the MSOT-values at a wavelength of 930 and 1064 nm(single time point (1 day))
- Correlation of acquired MSOT parameters with the ABI(single time point (1 day))
- Correlation of acquired MSOT parameters with the clinical severity of PAD(single time point (1 day))
- Muscular oxygenated/deoxygenated/total hemoglobin and the MSOT-values at a wavelength of 800nm before and after gait exposure(single time point (1 day))
- Difference between oxygenated/deoxygenated hemoglobin before and after gait exposure(single time point (1 day))
- Correlation of acquired MSOT parameters with the CCDS flow profile and PSV(single time point (1 day))
- Correlation of difference between oxygenated/deoxygenated hemoglobin with the TASC-classification (angiography)(single time point (1 day))
- Correlation of acquired MSOT parameters with the walking distance determined by treadmill examination(single time point (1 day))