Text Size

Microvascular Flow Assessment Repeatability Study: The MARS Study

This study has been terminated.
(Unable to reliably reproduce, visualize, or quantify microvascular flow in the subcutaneous tissue, the skeletal muscle or periadventitia (carotid or femoral).)
Sponsor:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01242020
First received: October 22, 2010
Last updated: December 2, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention
Healthy Volunteers
Obesity
 Drug: Perflutren Lipid Microsphere Injectable Suspension

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Microvascular Flow Assessment of the Periadventitial Adipose Tissue, Subcutaneous Adipose Tissue and Skeletal Muscle Using Contrast Enhanced Ultrasound (CEU); A Repeatability Study

Resource links provided by NLM:

MedlinePlus related topics: Obesity
Drug Information available for: Perflutren
U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Variability of Repeated Measures for Each Subject Is Less Than 5% [ Time Frame: up to 30 days ] [ Designated as safety issue: No ]
    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 is less than 5% in the overall cohort, and in the stratified groups of lean and obese subjects.


Secondary Outcome Measures:
  • The amount of microvascular flow in the periadventitial, subcutaneous and skeletal muscle tissues is different between lean and obese subjects. [ Time Frame: up to 30 days ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: October 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Ten (10) 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
Ten (10) 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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01242020

Locations
United States, Pennsylvania
Clinical and Translational Research Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Muredach P Reilly, MB, MSCE University of Pennsylvania
Study Director: Luis H. Eraso, MD, MPH University of Pennsylvania
  More Information

No publications provided

Responsible Party: Muredach P. Reilly, MB, MSCE, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01242020     History of Changes
Other Study ID Numbers: 811310
Study First Received: October 22, 2010
Last Updated: December 2, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013