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

This study has been terminated.
(Unable to reliably reproduce, visualize, or quantify microvascular flow in the subcutaneous tissue, the skeletal muscle or peri-adventitia)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01242020
First Posted: November 16, 2010
Last Update Posted: August 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Pennsylvania
  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
Obesity Drug: Perflutren Lipid Microsphere Injectable Suspension

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Variability of Repeated Measures for Each Subject [ Time Frame: 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.


Secondary Outcome Measures:
  • Microvascular Flow in the Periadventitial, Subcutaneous and Skeletal Muscle Tissues [ Time Frame: up to 30 days ]

Enrollment: 6
Actual Study Start Date: January 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01242020     History of Changes
Other Study ID Numbers: 811310
First Submitted: October 22, 2010
First Posted: November 16, 2010
Results First Submitted: July 13, 2017
Results First Posted: August 10, 2017
Last Update Posted: August 11, 2017
Last Verified: August 2017