Condition: Heart Diseases · Sponsor: Bracco Diagnostics, Inc
Interested? Contact the study team ↓
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).
This description comes directly from the study's public registry record.
Rushil Sankpal · 609-514-2267 · rushil.sankpal@diag.bracco.com
There is no obligation to join — the study team can answer your questions about taking part.
Always discuss trial participation with your own doctor first.
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.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| 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 |
| Oregon Health and Sciences University | Portland, Oregon, United States | Not Yet Recruiting |
| University of Texas Medical Branch | Galveston, Texas, United States | Withdrawn |
| Vital Heart and Vein | Humble, Texas, United States | Recruiting |
This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.
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