Peripheral Blood Flow Responses to Electromagnetic Energy
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 59 |
| Updated: | 2/10/2018 |
| Start Date: | November 2014 |
| End Date: | December 2019 |
| Contact: | Nicole L Lohr, MD, PhD |
| Email: | ntonn@mcw.edu |
| Phone: | 414-955-4261 |
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.
in healthy adults. All participants will receive red light to their leg. They will also
receive a continuous infusion of Definity (octafluoropropane) ultrasound contrast.
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.
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.
Inclusion Criteria:
- Participants will be healthy subjects over the age of 18.
- Men and women will be recruited for participation.
- All ethnicities will be included in this study.
Exclusion Criteria:
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.
We found this trial at
1
site
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
Milwaukee, Wisconsin
(414) 955-8296
Phone: 414-955-4261
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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