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

October 22, 2010
December 2, 2011
October 2010
June 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01242020 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Microvascular Flow Assessment Repeatability Study: The MARS Study
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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Healthy Volunteers
  • Obesity
Drug: Perflutren Lipid Microsphere Injectable Suspension
1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used
  • Ten (10) Lean Healthy Subjects
    "Lean" defined as (BMI ≥18 and ≤25)
    Intervention: Drug: Perflutren Lipid Microsphere Injectable Suspension
  • Ten (10) Obese Healthy Subjects
    Obese grade I-II defined as (BMI>30 and ≤35)
    Intervention: Drug: Perflutren Lipid Microsphere Injectable Suspension
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01242020
811310
No
Muredach P. Reilly, MB, MSCE, University of Pennsylvania
University of Pennsylvania
Not Provided
Principal Investigator: Muredach P Reilly, MB, MSCE University of Pennsylvania
Study Director: Luis H. Eraso, MD, MPH University of Pennsylvania
University of Pennsylvania
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP