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临床试验/NCT06966297
NCT06966297已完成不适用

Study of Calf Muscle Perfusion in Patients With Peripheral Arterial Disease After Revascularization Procedure Using Multispectral Optoacoustic Tomography

University Hospital Erlangen1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Hemoglobin associated parameters measured via Multispectral optoacoustic Tomography

研究概览

简要总结

The aim of the proposed study is to analyse the improvement of the calf muscle perfusion of patients with PAD Fontaine stage II and critical limb threatheaning ischemia (CLTI) after endovascular and surgical revascularization procedures using multispectral optoacoustic tomography (MSOT)

详细描述

Since 2021, the University Hospital Erlangen (department of pediatrics) disposes of a CE-certified multispectral optoacoustic tomograph (MSOT). Similar to sonography, the MSOT technology allows for non-invasive, quantitative imaging of the composition and also oxygenation of target tissues such as muscle.

Just like with conventional sonography, the MSOT transducer head is placed on the skin of the examined person above the target organ. But instead of sound waves, energy is applied to the tissue via flashes of laser light. This leads to constant changes of minimal expansions and contractions (thermoelastic expansion) of different tissue components or molecules. The same examination unit that sends in the laser flashes can also detect the emitted ultrasound waves. In the newly configured device (Acuity Echo, iThera Medical GmbH, Munich, CE-certified), an extended spectrum of laser light can be used, enabling among others the derivation of values corresponding to hemoglobin and its oxygenation levels. As hemoglobin concentration and oxygenation status are markers for perfusion, MSOT-based imaging of these parameters could be a highly sensitive and reliable method to analyze muscle perfusion.

These parameters have already been successfully measured, validated and reproduced in preliminary studies. Furthermore, a first internal study (MSOT_PAD, NCT04641091) confirmed the hypothesis that data collected via MSOT can be used for PAD diagnostics. The derived concentration of oxygenated hemoglobin (HbO2) proved to be the most suitable measurement parameter. Correlations could be established between the measured HbO2 concentration and the radiological and clinical severity of the PAD.

These results are very promising in terms of using the MSOT technique in diagnosis and monitoring of PAD. In particular, the establishment of this method would be of great value for the examination of PAD patients in whom, due to previous illness such as severe chronic renal insufficiency or diabetes mellitus, the measurement of the ABI or the CCDS examination do not provide valid results due to progressive stiffening of the vascular wall (Mönckeberg mediasclerosis). This also applies to patients who, due to previous illness or operations, cannot perform treadmill exercise to determine the absolute walking distance. With MSOT, an objectifiable measurement method for non-invasive monitoring of the actual target organ muscle could be established for the first time, which would be especially helpful in the mentioned patient groups. Up until now there are no non-invasive measurement methods other than MSOT that can make transcutaneous statements about muscle perfusion.

In the previous study (MSOT_PAD, NCT04641091), differentiability of clinical PAD stages improved after a standardized exercise of a walking distance of 150 meters, with patients in the stage of intermittent claudication (IC, Fontaine stage II) being harder to differentiate compared to patients in stage III and IV. For diagnostic methods that address macrocirculation (especially ABI and FKDS), provocation tests are routinely used in PAD diagnostics and already standardized. As a rule, patients with PAD are stressed up to their personal stress limit (ischemia pain). The respective examination is then repeated afterwards. This increases the ability to differentiate macrocirculatory variables, especially for minor pathologies. We assume that this also applies to the hemoglobin concentrations (at the microcirculation level), even though up until now there are no measurement methods for this.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosis of PAD confirmed by clinical examination and ABI (ABI ≤ 0.90)
  • •Planned for elective revascularization therapy
  • •Able to provide informed consent
  • •PAD stages II-IV Fontaine
  • •Age of > 18 years

排除标准

  • •Severe comorbid conditions
  • •Non-PAD related walking impairments (e.g., neurological disorders)
  • •Inability to comply with study protocols
  • •PAD stage I
  • •Age of < 18 years

结局指标

主要结局

Hemoglobin associated parameters measured via Multispectral optoacoustic Tomography

时间窗: 1 Hour

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ulrich Rother

Senior Physician

University Hospital Erlangen

研究点 (1)

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