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NCT06400004 · ClinicalTrials.gov registry record · Phase 3
Lumason® Infusion vs. Bolus Administrations
A Phase 3 study of Heart Diseases, sponsored by Bracco Diagnostics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 106
- Enrollment target
- 6
- Study locations
NCT06400004: Recruiting Phase 3 study of Heart Diseases, sponsored by Bracco Diagnostics.
NCT06400004 is a Phase 3 study of Heart Diseases that is actively recruiting participants, run by Bracco Diagnostics. The registered enrollment target is 106 participants, below the 5,531-participant average among 85 other Heart Diseases trials with a reported enrollment target (98% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06400004, a Phase 3 study of Heart Diseases, is actively recruiting participants, sponsored by Bracco Diagnostics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 106 participants
- Enrollment target
- 6
- Study locations
Study 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).
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Lumason
- DRUG Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]
Study Locations (6)
Texas
- University of Texas Medical Branch - Galveston
- Vital Heart and Vein - Humble
California
- Interventional Cardiology Medical Group - West Hills
Georgia
- Piedmont Heart Institute - Atlanta
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
Oregon
- Oregon Health and Sciences University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2024-07-10 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 3 |
What NCT06400004 shows while recruiting
NCT06400004 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 5,531-participant average among 85 other Heart Diseases trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Heart Diseases appearing as the primary indexed condition, and to 2 interventions - of which Lumason is the first listed.
NCT06400004 lists 6 locations in 5 states (Texas, California, Georgia).
Frequently Asked Questions
What is clinical trial NCT06400004 about?
NCT06400004 is a clinical study titled "Lumason® Infusion vs. Bolus Administrations". 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).
What is the current status of trial NCT06400004?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 106 participants. The study started on 2024-07-10. Estimated completion is 2026-12-31.
What conditions does trial NCT06400004 study?
This clinical trial studies the following conditions: Heart Diseases.
What interventions are being tested in trial NCT06400004?
The interventions under investigation include: Lumason (DRUG), Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON] (DRUG).
Who is sponsoring clinical trial NCT06400004?
This trial is sponsored by Bracco Diagnostics, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06400004 being conducted?
This trial has 6 study locations across California, Georgia, Massachusetts, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Diseases
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06400004's enrollment target sits among peer trials
106 68th of 85 higher than 18 of 85 other Heart Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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