Microvascular Flow Assessment Repeatability Study: The MARS Study

NCT ID: NCT01242020

Last Updated: 2017-08-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-05-31

Brief Summary

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.

Conditions

Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Lean Healthy Subjects

"Lean" defined as (BMI ≥18 and ≤25)

Group Type: OTHER

Perflutren Lipid Microsphere Injectable Suspension

Intervention Type: DRUG

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)

Group Type: OTHER

Perflutren Lipid Microsphere Injectable Suspension

Intervention Type: DRUG

1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used

Interventions

Perflutren Lipid Microsphere Injectable Suspension

1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Muredach P Reilly, MB, MSCE

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Luis H. Eraso, MD, MPH

Role: STUDY_DIRECTOR

University of Pennsylvania

Locations

Clinical and Translational Research Center

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

811310

Identifier Type: -

Identifier Source: org_study_id