Microvascular Flow Assessment Repeatability Study: The MARS Study

Stopped early · Not applicable

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT01242020

Run by

University of Pennsylvania

People needed

6

Starts

2011-01-01

Expected to finish

2011-05-01

Last updated by the study team

2017-08-11

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Vasculitis
• Peripheral arterial disease.
• Cancer
• 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

Where it is running

• Clinical and Translational Research Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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