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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
Results First Submitted: July 13, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition: Obesity
Intervention: Drug: Perflutren Lipid Microsphere Injectable Suspension

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Lean Healthy Subjects

"Lean" defined as (BMI ≥18 and ≤25)

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)

Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used


Participant Flow:   Overall Study
    Lean Healthy Subjects   Obese Healthy Subjects
STARTED   6   0 
COMPLETED   3   0 
NOT COMPLETED   3   0 
Withdrawal by Subject                2                0 
Failed screening                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Lean Healthy Subjects

"Lean" defined as (BMI ≥18 and ≤25)

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)

Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used

Total Total of all reporting groups

Baseline Measures
   Lean Healthy Subjects   Obese Healthy Subjects   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   0   6 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%   0      0   0.0% 
Between 18 and 65 years      6 100.0%   0      6 100.0% 
>=65 years      0   0.0%   0      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2  33.3%   0      2  33.3% 
Male      4  66.7%   0      4  66.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%   0      0   0.0% 
Asian      0   0.0%   0      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%   0      0   0.0% 
Black or African American      3  50.0%   0      3  50.0% 
White      3  50.0%   0      3  50.0% 
More than one race      0   0.0%   0      0   0.0% 
Unknown or Not Reported      0   0.0%   0      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Variability of Repeated Measures for Each Subject   [ Time Frame: up to 30 days ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination (not feasible with available equipment) leading to small number of subjects analyzed.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Muredach P. Reilly, MBBCh, MSCE
Organization: Associate Dean for Clinical and Translational Research, College of Physicians and Surgeons
phone: 212-305-9453
e-mail: mpr2144@cumc.columbia.edu



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