Trial Outcomes & Findings for Microvascular Flow Assessment Repeatability Study: The MARS Study (NCT NCT01242020)

NCT ID: NCT01242020

Last Updated: 2017-08-11

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

6 participants

Primary outcome timeframe

up to 30 days

Results posted on

2017-08-11

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	6	0
Overall Study COMPLETED	3	0
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Withdrawal by Subject	2	0
Overall Study Failed screening	1	0

Baseline Characteristics

Microvascular Flow Assessment Repeatability Study: The MARS Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lean Healthy Subjects n=6 Participants "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 n=6 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 30 days

Population: Reliable data for periadventitial microvascular flow, subcutaneous microvascular flow, and skeletal microvascular flow were not collected for the Outcome Measure.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 30 days

Population: Reliable data for periadventitial microvascular flow, subcutaneous microvascular flow, and skeletal muscle microvascular flow were not be collected for this outcome measure.

Outcome measures

Outcome data not reported

Adverse Events

Lean Healthy Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Obese Healthy Subjects

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Muredach P. Reilly, MBBCh, MSCE

Associate Dean for Clinical and Translational Research, College of Physicians and Surgeons

Phone: 212-305-9453

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place