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RecruitingPhase 3

Lumason® Infusion vs. Bolus Administrations

Bracco Diagnostics, Inc · NCT06400004

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
106
US sites recruiting
4
Study start
July 10, 2024
Record last updated
October 20, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]; Lumason

Conditions: Heart Diseases

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • Interventional Cardiology Medical Group

    West Hills, CA 91307

    Site contact: Michael Fam, MD · 818-743-0666 · mfam@elegantrd.com

  • Piedmont Heart Institute

    Atlanta, GA 30309

    Site contact: Suzanne Corley · 404-605-3118 · suzanne.corley@piedmont.org

  • Beth Israel Deaconess Medical Center

    Boston, MA 02215

    Site contact: Constance Angell-James, MPH · cangellj@bidmc.harvard.edu

  • Vital Heart and Vein

    Humble, TX 77338

    Site contact: Ovee Muhebb · 281-572-0109 · s.muhebb@vitalheartandvein.com

Study contacts (from the official record)

  • Rushil Sankpal · 609-514-2267 · rushil.sankpal@diag.bracco.com
Lumason® Infusion vs. Bolus Administrations (NCT06400004) | Bored Studies