Lumason® Infusion vs. Bolus Administrations

Официальное название

A Phase III Crossover Study to Evaluate Bolus Versus Continuous Infusion of Lumason® in Patients With Suboptimal Unenhanced Echocardiography

Обзор

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).

Подробное описание

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.

Вмешательства

• Препарат 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
• Препарат 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/min

Первичные конечные точки

• Adequate LV EBD Score [Срок оценки: 2-3 Hours]
• Adequate LV Opacification [Срок оценки: 2-3 Hours]

Вторичные конечные точки (2)

• Clinically useful LVO [Срок оценки: 2-3 Hours]
• Adverse events [Срок оценки: 24 Hours]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Диагностика

Центры проведения

США · 6 центров

• Interventional Cardiology Medical Group — West Hills
• Piedmont Heart Institute — Atlanta
• Beth Israel Deaconess Medical Center — Boston
• Oregon Health and Sciences University — Portland
• University of Texas Medical Branch — Galveston
• Vital Heart and Vein — Humble

Идентификаторы

NCT: NCT06400004 · BR1-149

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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