Microvascular Flow Assessment Repeatability Study: The MARS Study

N/ATerminatedNCT01242020

University of Pennsylvania6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Obesity

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Men and non-pregnant/lactating women between the ages of 18 and 45; 2. Lean (BMI ≥18 and ≤25) or Obese grade I-II(BMI\>30 and ≤35) 3. Provide written informed consent and sign HIPAA Waiver of Authorization 4. Be able and willing to follow all instructions and attend all study visits Exclusion Criteria: Subjects must not have been diagnosed with: 1. Coronary artery disease 2. Congestive heart failure 3. Congenital heart disease (Right-to-left, bi-directional, or transient right-to-left cardiac shunts) 4. Hypersensitivity to perflutren 5. Renal disease 6. Chronic obstructive pulmonary disease or Asthma 7. Primary or secondary pulmonary hypertension 8. Obstructive sleep apnea 9. Thyroid disease 10. Vasculitis 11. Peripheral arterial disease. 12. Cancer 13. Any type of immunosuppression 14. Any active infection (systemic or of the underlying skin or subcutaneous tissue). 15. Taking any prescribed medication for hypertension, dyslipidemia or diabetes. 16. Current or past smoking in the last 12 months. 17. Positive urine pregnancy test 18. Creatinine (Cr) above 1.4 mg/dl on screening evaluation 19. Hemoglobin (Hb) less than 10 mg/dl on screening evaluation 20. Aspartate Transaminase (AST) or Alanine Transaminase (ALT) two fold above upper limit of normal on screening evaluation

Outcomes

Primary Outcomes

Variability of Repeated Measures for Each Subject

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.

Time frame: up to 30 days

Secondary Outcomes

Microvascular Flow in the Periadventitial, Subcutaneous and Skeletal Muscle Tissues