[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06400004":3,"trial-entities:NCT06400004":188,"trial-summary:NCT06400004":192},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":44,"secondary_outcomes":52,"sex":60,"minimum_age":61,"maximum_age":62,"healthy_volunteers":15,"eligibility_criteria":63,"std_ages":80,"locations":83,"central_contacts":176,"overall_officials":181,"references":186,"see_also_links":187},"NCT06400004","BR1-149","Lumason® Infusion vs. Bolus Administrations","A Phase III Crossover Study to Evaluate Bolus Versus Continuous Infusion of Lumason® in Patients With Suboptimal Unenhanced Echocardiography","RECRUITING","2026-12-31","2026-03","2026-03-05","2024-07-10","Bracco Diagnostics, Inc","INDUSTRY",false,"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 is 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). The study will enroll patients with suboptimal LV EBD defined as ≥2 adjacent segments in any apical view that cannot be visualized at pre-contrast echocardiogram.",[19],"Heart Diseases",[],"INTERVENTIONAL","DIAGNOSTIC",[24],"PHASE3",{"count":26,"type":27},106,"ESTIMATED",[29,37],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":35},"DRUG","Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON]","Bolus administration of 2 mL undiluted Lumason®, to be administered in 20 seconds",[34],"Bolus administration",[36],"Bolus Administration",{"type":30,"name":38,"description":39,"armGroupLabels":40,"otherNames":42},"Lumason","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\u002Fmin",[41],"Continuous infusion",[43],"Infusion Administration",[45,49],{"measure":46,"description":47,"timeFrame":48},"Adequate LV EBD Score","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.","2-3 Hours",{"measure":50,"description":51,"timeFrame":48},"Adequate LV Opacification","Compare the proportion of patients with adequate LV opacification for infusion vs. bolus administrations in patients with suboptimal left ventricular endocardial border delineation at unenhanced echocardiography.",[53,56],{"measure":54,"description":55,"timeFrame":48},"Clinically useful LVO","To compare the duration of clinically useful LVO in infusion vs. bolus administrations in terms of duration",{"measure":57,"description":58,"timeFrame":59},"Adverse events","Compare adverse event rate after infusion vs. bolus administrations","24 Hours","ALL","18 Years",null,{"inclusion":64,"exclusion":68,"raw_text":79},[65,66,67],"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.",[69,70,71,72,73,74,75,76,77,78],"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.","Inclusion Criteria:\n\n* Are at least 18-years old;\n* Have suboptimal LV EBD, defined as ≥2 adjacent segments in any apical view that cannot be visualized, at pre-contrast echocardiogram;\n* Provide their written informed consent and are willing to comply with protocol requirements.\n\nExclusion Criteria:\n\n* Patient has severe congestive heart failure (class IV according to the classification of the New York Heart Association);\n* Patient has uncontrolled angina (i.e., uncontrolled on medication);\n* Patient had a recent myocardial infarction (within the last 3 days and not stabilized);\n* Patient has severe arrhythmia, that in the opinion of the Investigator, would interfere with the study conduct;\n* Patient has severe pulmonary hypertension, that in the opinion of the Investigator, would interfere with the study conduct;\n* Patient had been treated with any other contrast medium, either intravascular or orally, within 48 hours prior to the first administration;\n* Has any known allergy to one or more of the ingredients of the investigational product;\n* 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;\n* Has previously entered the study or have received any other investigational drug within 30 days prior to admission in this study;\n* Is determined by the Investigator that the patient is clinically unsuitable for the study.",[81,82],"ADULT","OLDER_ADULT",[84,102,117,134,153,162],{"facility":85,"status":8,"city":86,"state":87,"zip":88,"country":89,"contacts":90,"geoPoint":99},"Interventional Cardiology Medical Group","West Hills","California","91307","United States",[91,96],{"name":92,"role":93,"phone":94,"email":95},"Michael Fam, MD","CONTACT","818-743-0666","mfam@elegantrd.com",{"name":97,"role":98},"Farhad Rafii, MD","PRINCIPAL_INVESTIGATOR",{"lat":100,"lon":101},34.19731,-118.64398,{"facility":103,"status":8,"city":104,"state":105,"zip":106,"country":89,"contacts":107,"geoPoint":114},"Piedmont Heart Institute","Atlanta","Georgia","30309",[108,112],{"name":109,"role":93,"phone":110,"email":111},"Suzanne Corley","404-605-3118","suzanne.corley@piedmont.org",{"name":113,"role":98},"Venkateshwar Polsani, MD",{"lat":115,"lon":116},33.749,-84.38798,{"facility":118,"status":8,"city":119,"state":120,"zip":121,"country":89,"contacts":122,"geoPoint":131},"Beth Israel Deaconess Medical Center","Boston","Massachusetts","02215",[123,126,129],{"name":124,"role":93,"email":125},"Constance Angell-James, MPH","cangellj@bidmc.harvard.edu",{"name":127,"role":93,"email":128},"Madeline Cassidy","mcassid6@bidmc.harvard.edu",{"name":130,"role":98},"Jordan Strom, MD",{"lat":132,"lon":133},42.35843,-71.05977,{"facility":135,"status":136,"city":137,"state":138,"zip":139,"country":89,"contacts":140,"geoPoint":150},"Oregon Health and Sciences University","NOT_YET_RECRUITING","Portland","Oregon","97239",[141,145,147],{"name":142,"role":93,"phone":143,"email":144},"Amy Koski","503-360-6705","koskia@ohsu.edu",{"name":146,"role":98},"David German, MD",{"name":148,"role":149},"Brian Davidson, MD","SUB_INVESTIGATOR",{"lat":151,"lon":152},45.52345,-122.67621,{"facility":154,"status":155,"city":156,"state":157,"zip":158,"country":89,"geoPoint":159},"University of Texas Medical Branch","WITHDRAWN","Galveston","Texas","77555",{"lat":160,"lon":161},29.30135,-94.7977,{"facility":163,"status":8,"city":164,"state":157,"zip":165,"country":89,"contacts":166,"geoPoint":173},"Vital Heart and Vein","Humble","77338",[167,171],{"name":168,"role":93,"phone":169,"email":170},"Ovee Muhebb","281-572-0109","s.muhebb@vitalheartandvein.com",{"name":172,"role":98},"Patrick Kee, MD",{"lat":174,"lon":175},29.99883,-95.26216,[177],{"name":178,"role":93,"phone":179,"email":180},"Rushil Sankpal","609-514-2267","rushil.sankpal@diag.bracco.com",[182],{"name":183,"affiliation":184,"role":185},"Jose Banchs, MD","Sr. Medical Director","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":189,"biomarkers":191},[190],"Heart Disorder",[],{"nct_id":4,"found":193,"summary":194,"prompt_version":204},true,{"design":195,"status":196,"heading":197,"summary":198,"follow_up":199,"word_count":200,"commitments":201,"compensation":202,"drugs_mentioned":203},"This is a Phase 3 randomized study comparing two ways of giving Lumason® within the same patient. It plans to enroll 106 participants.","completed","Lumason® Infusion vs. Bolus Administrations for Heart Disease","This study is looking at two different ways to give Lumason®, a medication used to improve heart imaging. Researchers want to see if giving Lumason® as a continuous infusion (slowly over time) works better than giving it as a quick bolus (a single, fast injection) for people with certain heart conditions. You might be able to join if you are at least 18 years old and have difficulty seeing parts of your heart clearly on an echocardiogram (an ultrasound of the heart). The study will compare how well each method helps visualize your heart and how well the left ventricle (the main pumping chamber of your heart) is filled with the contrast agent. The study plans to enroll 106 participants, but its current recruitment status is unclear.","The main measurements for this study will be taken 2-3 hours after the Lumason® administration.",127,"Not specified in the trial record.","Not stated in the trial record.",[38],"v2"]