Continuous diluted Lumason infusion versus undiluted Lumason bolus for clearer left‑ventricle ultrasound images

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III, randomized within‑patient comparison has each participant receive both a continuous diluted infusion of Lumason and an undiluted bolus in randomized order to compare image quality. The co‑primary endpoints are degree of left ventricular opacification (LVO) and improvement in left ventricular endocardial border definition (LV EBD). Eligible patients are adults with suboptimal LV EBD defined as at least two adjacent segments not visualized in any apical view on pre‑contrast echocardiography. The trial is being conducted at multiple U.S. cardiac centers and uses standard echocardiographic imaging with contrast to score the endpoints.

Why it matters

Who can join: the full rules

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.

Where it's running

• Interventional Cardiology Medical Group
  West Hills, California, United States Recruiting
• Piedmont Heart Institute
  Atlanta, Georgia, United States Recruiting
• Beth Israel Deaconess Medical Center
  Boston, Massachusetts, United States Recruiting
• Vital Heart and Vein
  Humble, Texas, United States Recruiting
• Oregon Health and Sciences University
  Portland, Oregon, United States Not yet recruiting
• University of Texas Medical Branch
  Galveston, Texas, United States Withdrawn

Study contacts

• Study coordinator: Rushil Sankpal
• Email: rushil.sankpal@diag.bracco.com
• Phone: 609-514-2267

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.