Peripheral Blood Flow Responses to Electromagnetic Energy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in blood flow (using octafluoropropane infusion and ultrasound)
研究概览
简要总结
This study evaluates 670 nm energy in the form of red light to stimulate blood flow changes in healthy adults. All participants will receive red light to their leg. They will also receive a continuous infusion of Definity (octafluoropropane) ultrasound contrast.
详细描述
670 nm energy in the form of red light dilates isolated blood vessels. This study seeks to measure vessel dilation in human subjects exposed to this energy at different irradiance intensities (25 milliwatts (mW)/cm2 and 75 mW/cm2). The intent of this protocol is to measure blood flow in the gastrocnemius muscle before and after exposure to 670 nm light energy. This protocol will be performed in healthy subjects, who do not meet exclusion criteria. The study consists of one visit. Blood flow measurement will be performed using contrast enhanced ultrasound, a method by which ultrasound contrast is continuously infused into the blood stream. Ultrasound records images in the area of interest and flow is related to the intensity of the contrast in each image. After baseline blood flow images are collected, the subject will receive red light energy to the gastrocnemius muscle with concurrent blood flow measurements with contrast ultrasound. The subject will be monitored post procedure and the study will then be completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants will be healthy subjects over the age of
- •Men and women will be recruited for participation.
- •All ethnicities will be included in this study.
排除标准
- •Exclusionary criteria include:
- •age under 18 years and those over 60 years of age,
- •those who are unable to understand the consent process,
- •those who cannot read or speak English,
- •a history of cancer,
- •peripheral artery disease,
- •diabetes mellitus,
- •active pregnancy,
- •hypersensitivity to perflutren contrast agents,
- •pulmonary hypertension,
- •chronic kidney disease,
- •active tobacco or drug use,
- •blood pressure over 160/90, BMI>30,
- •sickle cell disease, or
- •history of intracardiac shunt.
- •Additional exclusion criteria include:
- •a history of coronary artery disease,
- •heart failure,
- •the presence of an implanted defibrillator or pacemaker,
- •a history of heart murmur or rhythm disorder (atrial fibrillation, atrial tachycardia, or ventricular tachycardia),
- •neurological diseases such as stroke, and
- •any uncontrolled medical conditions.
研究组 & 干预措施
670 nm light
Subjects will have baseline blood flow measured in the gastrocnemius using octafluoropropane infusion and ultrasound.After baseline flow measurements are obtained, a 670 nm light emitting diode will be placed 1 cm above the gastrocnemius muscle. The diode will not be in direct contact with the skin. Subjects will be exposed to 75 mW/cm2. Contrast images will be obtained up to 5 minutes after the commencement of light.
干预措施: 670 nm light (Device)
670 nm light
Subjects will have baseline blood flow measured in the gastrocnemius using octafluoropropane infusion and ultrasound.After baseline flow measurements are obtained, a 670 nm light emitting diode will be placed 1 cm above the gastrocnemius muscle. The diode will not be in direct contact with the skin. Subjects will be exposed to 75 mW/cm2. Contrast images will be obtained up to 5 minutes after the commencement of light.
干预措施: octafluropropane (Drug)
结局指标
主要结局
Change in blood flow (using octafluoropropane infusion and ultrasound)
时间窗: 10 minutes
Blood flow changes based on ultrasound imaging
次要结局
未报告次要终点
研究者
Nicole Lohr
Professor
University of Alabama at Birmingham