Lumason® Infusion vs. Bolus Administrations

Part of paid clinical trials in West Hills, California.

Sponsor
Bracco Diagnostics, Inc
Study ID
NCT06400004
Phase
PHASE3
Status
Recruiting
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Conditions

  • Heart Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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).

Key Dates

Start date
Jul 10, 2024
Status verified
Mar 2026
Primary completion
May 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
106 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Bolus administration
    Bolus administration of 2 mL undiluted Lumason®
  • Experimental: Continuous infusion
    Continuous infusion of 8 mL of diluted Lumason®

Primary Outcome Measure

Adequate LV EBD Score [ Time Frame: 2-3 Hours ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Interventional Cardiology Medical GroupWest HillsCalifornia91307
Michael Fam, MD
[email protected]
818-743-0666
Farhad Rafii, MD (PRINCIPAL_INVESTIGATOR)
Piedmont Heart InstituteAtlantaGeorgia30309
Suzanne Corley
[email protected]
404-605-3118
Venkateshwar Polsani, MD (PRINCIPAL_INVESTIGATOR)
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Constance Angell-James, MPH
[email protected]
Madeline Cassidy
[email protected]
Jordan Strom, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health and Sciences UniversityPortlandOregon97239
Amy Koski
[email protected]
503-360-6705
David German, MD (PRINCIPAL_INVESTIGATOR)
Brian Davidson, MD (SUB_INVESTIGATOR)
University of Texas Medical BranchGalvestonTexas77555-
Vital Heart and VeinHumbleTexas77338
Ovee Muhebb
[email protected]
281-572-0109
Patrick Kee, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in West Hills, CA

By research site
Interventional Cardiology Medical Group· West Hills, CAPiedmont Heart Institute· Atlanta, GABeth Israel Deaconess Medical Center· Boston, MAOregon Health and Sciences University· Portland, ORUniversity of Texas Medical Branch· Galveston, TXVital Heart and Vein· Humble, TX

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