Health TrialsbyHealthPanel

Lumason® Infusion vs. Bolus Administrations

ConditionHeart Diseases
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBracco Diagnostics, Inc

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Crossover

Treatments tested in this trial

  • Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]

    Drug

    Bolus administration of 2 mL undiluted Lumason®, to be administered in 20 seconds

  • Lumason

    Drug

    Continuous infusion of 8 mL of diluted Lumason® (4 mL of Lumason® diluted in 4 mL of saline) at a rate of 1.0 mL/min

Treatment groups

106 Participants
are divided into 2 treatment groups
Group A: Bolus administrationActive comparator 1 intervention
Group B: Continuous infusionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adequate LV EBD Score

Compare the proportion of patients with adequate LV EBD score for infusion vs. bolus administrations in patients with suboptimal left ventricular endocardial border delineation at unenhanced echocardiography.

Time frame
2-3 Hours
2

Adequate LV Opacification

Compare the proportion of patients with adequate LV opacification for infusion vs. bolus administrations in patients with suboptimal left ventricular endocardial border delineation at unenhanced echocardiography.

Time frame
2-3 Hours

Secondary outcomes

1

Clinically useful LVO

To compare the duration of clinically useful LVO in infusion vs. bolus administrations in terms of duration

Time frame
2-3 Hours
2

Adverse events

Compare adverse event rate after infusion vs. bolus administrations

Time frame
24 Hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bracco Diagnostics, Inc

Lead sponsor

Source ClinicalTrials.gov
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