16
Participants
Start Date
April 25, 2019
Primary Completion Date
September 30, 2024
Study Completion Date
May 6, 2025
Echocardiogram
"Images will be recorded in parasternal long, short axis, apical four, two, and three chamber views according to the American Society of Echocardiography (ASE) 17 segment model. Each assessment will include one round of low MI imaging (\<0.3) and one round of very low MI imaging (\<0.2) in each of the pre-specified windows according to the 2014 ASE Sonographer Guidelines.~A baseline echocardiogram will be performed prior to the administration of DEFINITY® or MVT-100. Assessments will be made three times, once from 0 - 1 ½ minutes following injection, once between 1 ½ minutes to 3 minutes following IV injection and once from 3 - 4 ½ minutes following IV injection. Assessments at each time point will include one round of low MI imaging (\<0.3) and one round of very low MI imaging (\<0.2). Each round will include the views in the following order: parasternal long, parasternal short, apical 4, apical 2 and apical 3."
MVT-100
After randomization, MVT-100, the experimental drug, is administered via IV infusion or bolus administration and echocardiograms are subsequently obtained.
Definity
After randomization, Definity, the active comparator, is administered via IV infusion or bolus administration and echocardiograms are subsequently obtained.
Saint Luke's Hospital of Kansas City, Kansas City
University of Nebraska Medical Center, Omaha
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Nebraska
OTHER
Microvascular Therapeutics, LLC
INDUSTRY