Microvascular Flow Assessment of the Periadventitial Adipose Tissue, Subcutaneous Adipose Tissue and Skeletal Muscle Using Contrast Enhanced Ultrasound (CEU); A Repeatability Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Variability of Repeated Measures for Each Subject
研究概览
简要总结
The purpose of this study is to test a method of imaging (taking a picture) of the abdomen (belly), neck, thigh and calf (lower leg) areas of the body, using ultrasound along with a drug which makes the pictures look clearer. Ultrasound is a type of imaging that uses sound waves to create a picture of the inside of the human body. Two sets of pictures will be taken on two different days to see if the results are the same each time.
DEFINITY® is a drug given intravenously (through the vein). DEFINITY® is approved by the FDA to be used as an ultrasound contrast agent (makes the pictures look clearer) while taking pictures of the heart. In this study, DEFINITY® will be used while taking pictures of blood vessels in your abdomen (belly), neck, thigh and calf (lower leg). Since this use of DEFINITY® is different than the use approved by the FDA, this study will be performed under an FDA Investigational New Drug (IND) application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and non-pregnant/lactating women between the ages of 18 and 45;
- •Lean (BMI ≥18 and ≤25) or Obese grade I-II(BMI>30 and ≤35)
- •Provide written informed consent and sign HIPAA Waiver of Authorization
- •Be able and willing to follow all instructions and attend all study visits
排除标准
- •Subjects must not have been diagnosed with:
- •Coronary artery disease
- •Congestive heart failure
- •Congenital heart disease (Right-to-left, bi-directional, or transient right-to-left cardiac shunts)
- •Hypersensitivity to perflutren
- •Renal disease
- •Chronic obstructive pulmonary disease or Asthma
- •Primary or secondary pulmonary hypertension
- •Obstructive sleep apnea
- •Thyroid disease
- •Peripheral arterial disease.
- •Any type of immunosuppression
- •Any active infection (systemic or of the underlying skin or subcutaneous tissue).
- •Taking any prescribed medication for hypertension, dyslipidemia or diabetes.
- •Current or past smoking in the last 12 months.
- •Positive urine pregnancy test
- •Creatinine (Cr) above 1.4 mg/dl on screening evaluation
- •Hemoglobin (Hb) less than 10 mg/dl on screening evaluation
- •Aspartate Transaminase (AST) or Alanine Transaminase (ALT) two fold above upper limit of normal on screening evaluation
研究组 & 干预措施
Lean Healthy Subjects
"Lean" defined as (BMI ≥18 and ≤25)
干预措施: Perflutren Lipid Microsphere Injectable Suspension (Drug)
Obese Healthy Subjects
Obese grade I-II defined as (BMI>30 and ≤35)
干预措施: Perflutren Lipid Microsphere Injectable Suspension (Drug)
结局指标
主要结局
Variability of Repeated Measures for Each Subject
时间窗: up to 30 days
The variability of repeated measures for each subject, expressed as coefficient of variation (CV), in the periadventitial microvascular flow, subcutaneous microvascular flow and skeletal muscle flow.
次要结局
- Microvascular Flow in the Periadventitial, Subcutaneous and Skeletal Muscle Tissues(up to 30 days)