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临床试验/NCT06541496
NCT06541496招募中不适用

Influence of Fitzpatrick Skin Phototype and Body Mass Index on Non-invasive Optoacoustic Imaging of Muscle During Vascular Restriction and Physical Activity

University of Erlangen-Nürnberg Medical School1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2024年6月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
130
试验地点
1
主要终点
Quantitative hemoglobin-associated signal (in arbitrary units)

研究概览

简要总结

Multispectral Optoacoustic Tomography (MSOT) is a promising imaging technology that utilizes pulsed laser light. While melanin content in the skin has been reported to influence light-based measurements in pulse oximetry and near-infrared spectroscopy, its effects on MSOT are not well understood. This proposed study aims to investigate how different Fitzpatrick skin phenotypes (FSP) and body mass index (BMI) influence muscle perfusion and oxygenation during arterial occlusion and muscle exercise over time. Healthy volunteers with varying skin tones (as defined by FSP) and BMI will be recruited and subjected to leg arterial occlusion and toe raise exercises. They will then be scanned on different body areas (arms and legs) to assess changes in muscle perfusion and oxygenation using MSOT.

详细描述

Melanin, a pigment found in the skin, has been reported to influence light-based measurements such as pulse oximetry or near-infrared spectroscopy (NIRS). Studies have shown measurements overestimation of darker skin tones or in ethnicities assumed to have darker skin tones compared to lighter skin tones. Even though optoacoustic imaging (OAI) has a different depth penetration than NIRS or pulse oximetry, the technology uses pulse laser light to assess tissue.

Multispectral Optoacoustic Tomography (MSOT) imaging is similar to conventional sonography: a transducer is placed on the skin, and instead of sound, energy is applied to the tissue by means of pulsed laser light. This leads to a constant change of minimal expansion and contraction of individual tissue components or molecules. The resulting sound waves can then be detected by the same device. Previous studies have already shown that the quantitative determination of hemoglobin can provide information on inflammatory activities or muscle hemodynamics. MSOT uses laser light between 660 and 1300nm to visualize and quantify different endogenous chromophores, such as hemoglobin, collagen, or melanin. Increase in melanin concentration (e.g. in melanomas or skin tags) has been previously assessed using the technology but never looked at signal at depth. Additionally, differences in body-mass-index (BMI) might influence light penetration, and therefore, the optoacoustic signal at depth. So far, no studies have looked at the influence of increased melanin concentration or subcutaneous fat on quantification of muscle perfusion and oxygenation.

In this first pilot study, the aim is to investigate the influence of different Fitzpatrick skin phenotypes (FSP) and BMI on muscle perfusion and oxygenation during arterial occlusion or muscle exercise and over time. This information is essential for further studies with a more diverse study population.

To gain insights into these differences, healthy volunteers with different skin tone (defined by FSP) and body-mass-index will be recruited and subjected to a leg arterial occlusion and to perform a toe raise exercise. They will then be scanned on different body areas (arm, legs) to assess changes in muscle perfusion and oxygenation by MSOT.

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

入选标准

  • Signed informed consent

排除标准

  • Pregnancy
  • diagnosed diabetes
  • diagnosed renal insufficiency
  • diagnosed Peripheral arterial disease
  • diagnosed muscle associated disease
  • tattoos in scan area
  • missing consent form

结局指标

主要结局

Quantitative hemoglobin-associated signal (in arbitrary units)

时间窗: immediately before and after intervention (occlusion and exercise)

Hemoglobin signal in the measured muscle regions in all different cohorts

次要结局

  • Heart rate (in bpm)(immediately before and after intervention (occlusion and exercise))
  • Dominant side(baseline)
  • Sport frequency(baseline)
  • Muscle oxygenation (in arbitrary units)(immediately before and after intervention (occlusion and exercise))
  • Oxygen saturation (in %)(immediately before and after intervention (occlusion and exercise))
  • Weight (in kg)(baseline)
  • Gender: male, female, other(baseline)
  • Skin tone based on Fitzpatrick scale examiner-assessment (type 1-6, 1 being the palest, 6 being the darkest)(baseline)
  • Skin tone based on Fitzpatrick scale self-assessment (type 1-6, 1 being the palest, 6 being the darkest)(baseline)
  • Blood pressure (in mm Hg)(immediately before and after intervention (occlusion and exercise))
  • Age in years(baseline)
  • Skin tone based on Fitzpatrick questionnaire self-assessment (type 1-6, 1 being the palest, 6 being the darkest)(baseline)
  • Quantitative collagen, lipid, water and melanin signal (in arbitrary units)(immediately before and after intervention (occlusion and exercise))
  • Information on last physical exercise and caffeine and alcohol consumption(baseline)

研究者

发起方
University of Erlangen-Nürnberg Medical School
申办方类型
Other
责任方
Sponsor

研究点 (1)

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