Microvascular Flow Assessment Repeatability Study: The MARS Study (MARS)

Microvascular Flow Assessment of the Periadventitial Adipose Tissue, Subcutaneous Adipose Tissue and Skeletal Muscle Using Contrast Enhanced Ultrasound (CEU); A Repeatability Study

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 Overview

• Status: Terminated
• Conditions: Obesity
• Intervention / Treatment: Drug: Perflutren Lipid Microsphere Injectable Suspension

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Clinical and Translational Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Lean Healthy Subjects; "Lean" defined as (BMI ≥18 and ≤25)	Drug: Perflutren Lipid Microsphere Injectable Suspension; 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used
Other: Obese Healthy Subjects; Obese grade I-II defined as (BMI>30 and ≤35)	Drug: Perflutren Lipid Microsphere Injectable Suspension; 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Microvascular Flow in the Periadventitial, Subcutaneous and Skeletal Muscle Tissues	up to 30 days

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Muredach P Reilly, MB, MSCE, University of Pennsylvania; Study Director: Luis H. Eraso, MD, MPH, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: October 22, 2010
• First Submitted That Met QC Criteria: November 12, 2010
• First Posted (Estimate): November 16, 2010

Study Record Updates

• Last Update Posted (Actual): August 11, 2017
• Last Update Submitted That Met QC Criteria: August 10, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 811310