Lumason® Infusion vs. Bolus Administrations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-30

Study Completion Date

2024-12-31

Brief Summary

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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).

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Detailed Description

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This is 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). The study will enroll patients with suboptimal LV EBD defined as ≥2 adjacent segments in any apical view that cannot be visualized at pre-contrast echocardiogram.

Conditions

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Heart Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Bolus administration

Bolus administration of 2 mL undiluted Lumason®

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Continuous infusion

Continuous infusion of 8 mL of diluted Lumason®

Group Type EXPERIMENTAL

Lumason

Intervention Type 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

Interventions

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

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

Intervention Type DRUG

Lumason

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

Intervention Type DRUG

Other Intervention Names

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Bolus Administration Infusion Administration

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No