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Lumason® Infusion vs. Bolus Administrations | Clinical Trials | Clareo Health

RECRUITINGPHASE3

Lumason® Infusion vs. Bolus Administrations

A Phase III Crossover Study to Evaluate Bolus Versus Continuous Infusion of Lumason® in Patients With Suboptimal Unenhanced Echocardiography

NCT06400004•Bracco Diagnostics, Inc

View on ClinicalTrials.gov

Summary

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).

Detailed Description

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (6)

Interventional Cardiology Medical Group

West Hills, California, United States

Piedmont Heart Institute

Atlanta, Georgia, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Oregon Health and Sciences University

Portland, Oregon, United States

University of Texas Medical Branch

Galveston, Texas, United States

Vital Heart and Vein

Humble, Texas, United States

Key Dates

Start Date

July 10, 2024

Primary Completion Date

May 31, 2026

Completion Date

December 31, 2026

Last Updated

March 5, 2026

Enrollment

106

ESTIMATED participants

Conditions

Heart Diseases

Interventions

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

DRUG

Lumason

DRUG

Contacts

Rushil Sankpal

CONTACT

609-514-2267 rushil.sankpal@diag.bracco.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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