Peripheral Vascular DiseaseNCT04641091
Muscle Perfusion in Patients With PAD by Non-invasive MSOT
An observational study of Peripheral Vascular Disease and Peripheral Arterial Disease, run by University Hospital Erlangen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Disease, Peripheral Arterial Disease
- What is being tested?
- Multispectral Optoacustic Tomography (MSOT)
- Type of treatment
- Medical device
- How many people
- 220 participants
- Where
- 1 siteGermany
- Study dates
- 13 Nov 2020to 18 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cross-sectional Study of Muscle Perfusion in Patients With PAD by Non-invasive Multispectral Optoacoustic Tomography
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.
Read the 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.
- Being tested
- Multispectral Optoacustic Tomography (MSOT)
- 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
- Medical subject headings
- Peripheral Vascular Diseases, Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multispectral Optoacustic Tomography (MSOT)Device
non-invasive transcutaneous imaging of subcellular muscle components
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Multispectral Optoacustic Tomography (MSOT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Quantitative oxygenated/deoxygenated/total hemoglobin signal and signal at a wavelength of 800 nm (Units: arbitrary units (a. u.)) derived by transcutaneous MSOT in patients with PAD before gait exposure compared to the signals after gait exposure
Measured: 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)
Quantitative oxygenated/deoxygenated/total hemoglobin signal and signal at a wavelength of 800 nm(Units: arbitrary units (a. u.)) derived by transcutaneous MSOT in patients with PAD correlated with the TASC-classification (angiography)
Measured: single time point (1 day)
Difference between oxygenated/deoxygenated hemoglobin before and after gait exposure
Difference between quantitative oxygenated hemoglobin amount (Units: arbitrary units (a. u.)) and quantitative deoxygenated hemoglobin amount (Units: arbitrary units (a. u.)) derived by transcutaneous MSOT in patients with PAD before gait exposure compared to the amount after gait exposure
Measured: single time point (1 day)
Correlation of difference between oxygenated/deoxygenated hemoglobin with the TASC-classification (angiography)
Difference between quantitative oxygenated hemoglobin amount (Units: arbitrary units (a. u.)) and quantitative deoxygenated hemoglobin amount (Units: arbitrary units (a. u.)) derived by transcutaneous MSOT in patients with PAD correlated with the TASC-classification (angiography)
Measured: single time point (1 day)
Muscular quantitative lipid/collagen signal fraction and the MSOT-values at a wavelength of 930 and 1064 nm
Quantitative lipid/collagen signals and signals at 930 and 1064 nm (Units: arbitrary units (a. u.)) derived by transcutaneous MSOT in patients with different clinical and angiographic PAD stages
Measured: single time point (1 day)
Correlation of acquired MSOT parameters with the CCDS flow profile and PSV
Quantitative oxygenated/deoxygenated/total hemoglobin content and MSOT-values at a wavelength of 800 nm (Units: arbitrary units (a. u.)) derived by transcutaneous MSOT in patients with PAD correlated with the flow profile and PSV of A. CFA and A. poplitea determined by CCDS
Measured: single time point (1 day)
Correlation of acquired MSOT parameters with the ABI
Quantitative oxygenated/deoxygenated/total hemoglobin content and MSOT-values at a wavelength of 800 nm (Units: arbitrary units (a. u.)) derived by transcutaneous MSOT correlated with the ABI
Measured: single time point (1 day)
Correlation of acquired MSOT parameters with the walking distance determined by treadmill examination
Quantitative oxygenated/deoxygenated/total hemoglobin content and MSOT-values at a wavelength of 800 nm (Units: arbitrary units (a. u.)) derived by transcutaneous MSOT correlated with the walking distance determined by treadmill examination
Measured: single time point (1 day)
Correlation of acquired MSOT parameters with the clinical severity of PAD
Quantitative oxygenated/deoxygenated/total hemoglobin content and MSOT-values at a wavelength of 800 nm (Units: arbitrary units (a. u.)) derived by transcutaneous MSOT correlated with the clinical severity of PAD according to Fontaine and Rutherford
Measured: single time point (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start13 Nov 2020
- Primary completion1 Oct 2021
- Study completion18 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Erlangen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulrich Rother, University Hospital Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04641091
- Sponsor's protocol ID
- MSOT_PAD
- Status last verified
- Feb 2022
- First submitted
- 17 Nov 2020
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 15578331Alpert 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.
PubMed 4885945
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-sectional Study of Muscle Perfusion in Patients With PAD by Non-invasive Multispectral Optoacoustic Tomography
- ClinicalTrials.gov ID
- NCT04641091
- Acronym / sponsor ID
- MSOT_PAD
- Keywords
- Peripheral Vascular Disease, Peripheral Arterial Disease, Multispectral Optoacoustic Tomography, Revascularization, Claudicatio intermittens, Critical limb ischemia, MSOT, CLI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University Hospital ErlangenUniversity, hospital or other
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 18 Feb 2022 (actual)
- First posted
- 23 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group 1 | – | Device: Multispectral Optoacustic Tomography (MSOT)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 |
| Study group 2 | – | Device: Multispectral Optoacustic Tomography (MSOT)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multispectral Optoacustic Tomography (MSOT)non-invasive transcutaneous imaging of subcellular muscle components | Device | Study group 1, Study group 2 |
Primary outcome
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
9 secondary outcomes
Muscular oxygenated/deoxygenated/total hemoglobin and the MSOT-values at a wavelength of 800nm before and after gait exposure
Time frame: 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)
Time frame: single time point (1 day)
Difference between oxygenated/deoxygenated hemoglobin before and after gait exposure
Time frame: single time point (1 day)
Correlation of difference between oxygenated/deoxygenated hemoglobin with the TASC-classification (angiography)
Time frame: single time point (1 day)
Muscular quantitative lipid/collagen signal fraction and the MSOT-values at a wavelength of 930 and 1064 nm
Time frame: single time point (1 day)
Correlation of acquired MSOT parameters with the CCDS flow profile and PSV
Time frame: single time point (1 day)
Correlation of acquired MSOT parameters with the ABI
Time frame: single time point (1 day)
Correlation of acquired MSOT parameters with the walking distance determined by treadmill examination
Time frame: single time point (1 day)
Correlation of acquired MSOT parameters with the clinical severity of PAD
Time frame: single time point (1 day)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
- Background: PubMed 15578331Lange 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.
- Background: PubMed 4885945Alpert 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Vascular Disease and Peripheral Arterial Disease, run by University Hospital Erlangen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Derivation of optimal diagnostic MSOT thresholds for hemoglobin (time frame: single time point (1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04641091, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2022.