No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Diagnostic
Participants needed
106 (estimated)
Sponsor
Bracco Diagnostics, Inc · Industry
Who this trial is looking for
This trial is looking for adults with heart health issues to compare two ways of giving a heart imaging substance called Lumason®. Participants will receive either a continuous drip or a quick injection of Lumason®.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have trouble seeing parts of my heart in an ultrasound.
I can give my written consent.
I am willing to follow the trial's rules.
You may not be able to join if
I have severe heart failure.
I have uncontrolled chest pain.
I had a heart attack in the last 3 days.
I have severe heart rhythm problems.
I have severe lung high blood pressure.
I took another contrast medium in the last 48 hours.
I am allergic to any ingredients in Lumason®.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
A phase III study designed as a randomized, within-patient comparison of continuous infusion of diluted Lumason® versus the bolus administration of undiluted Lumason® for degree of LVO and assessment of LV EBD (co-primary endpoints).
Trial Locations
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City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
* Are at least 18-years old;
* Have suboptimal LV EBD, defined as ≥2 adjacent segments in any apical view that cannot be visualized, at pre-contrast echocardiogram;
* Provide their written informed consent and are willing to comply with protocol requirements.
Exclusion Criteria…
Inclusion Criteria:
* Are at least 18-years old;
* Have suboptimal LV EBD, defined as ≥2 adjacent segments in any apical view that cannot be visualized, at pre-contrast echocardiogram;
* Provide their written informed consent and are willing to comply with protocol requirements.
Exclusion Criteria:
* Patient has severe congestive heart failure (class IV according to the classification of the New York Heart Association);
* Patient has uncontrolled angina (i.e., uncontrolled on medication);
* Patient had a recent myocardial infarction (within the last 3 days and not stabilized);
* Patient has severe arrhythmia, that in the opinion of the Investigator, would interfere with the study conduct;
* Patient has severe pulmonary hypertension, that in the opinion of the Investigator, would interfere with the study conduct;
* Patient had been treated with any other contrast medium, either intravascular or orally, within 48 hours prior to the first administration;
* Has any known allergy to one or more of the ingredients of the investigational product;
* Is pregnant or lactating. Exclude the possibility of pregnancy by: testing on site (serum or urine βHCG) prior to the start of investigational product administration; surgical history (e.g., tubal ligation or hysterectomy); post-menopausal with a minimum 1 year without menses;
* Has previously entered the study or have received any other investigational drug within 30 days prior to admission in this study;
* Is determined by the Investigator that the patient is clinically unsuitable for the study.
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