Cardiac Diseases
Conditions
Keywords
Echo, Echocardiogram, Cardiac ultrasound, suboptimal, contrast agent, enhancing agent, LVO, LVEBD
Brief summary
This is a Phase 3, prospective, open-label, multicenter study to assess the efficacy of NH002-enhanced echocardiography in subjects with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the left ventricular endocardial border delineation compared with unenhanced echocardiography. The study also aims to investigate the safety and tolerability of NH002.
Interventions
NH002 is formulated as a microbubble injectable suspension for intravenous administration. NH002 requires an activation process prior to use.
Sponsors
Trust Bio-sonics, Inc.
CMIC ASIA-PACIFIC, PTE. LTD., TAIWAN BRANCH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age or older 2. Ability to understand and the willingness to provide written informed consent 3. Having or suspected of having cardiac disease 4. Undergone a transthoracic echo within 30 days prior to NH002 dose administration, resulting in suboptimal LVEBD, as defined by 2 or more segments of 6 segments of the ventricular border that cannot be visualized reliably in any of the standard apical 4-, 2-, and 3-chamber views during the resting non-contrast ultrasound examination
Exclusion criteria
Subjects will be excluded from the study if one or more of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left Ventricular Endocardial Border Delineation (LVEBD) | Image data obtained pre-injection and within 10 minutes post-injection | The first primary efficacy endpoint will be the change from baseline in total LVEBD scores (UEUS vs CEUS) defined using a 16-segment model derived from the standard 17-segment model, as assessed through blinded central reading. The LV endocardium of the standard apical 4-, 2-, and 3-chamber views is divided into 6 segments, with 2 basal, mid-, and apical segments in each view, of which 2 segments are shared in the standard apical 4- and 3-chamber views (i.e., a total of 16 segments in the 3 views). The 17th segment at the apex will not be scored since it does not connect to any part of the LV endocardial border. For each segment, LVEBD is graded as follows: 0 = inadequate border (border not visible); 1 = sufficient (border barely visible); 2 = good (border clearly visible). A total delineation score (0 to 32) is obtained by adding the scores from a total of the 16 segments in the 3 views. |
| Left Ventricular Opacification (LVO) | Image data obtained pre-injection and within 10 minutes post-injection | The co-primary endpoint will be the proportion of subjects with adequate LVO defined by an LVO grade of +2 (moderate) or +3 (complete), as assessed through blinded central reading. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number and percentage of subjects with suboptimal echocardiography converted into optimal echocardiography | Image data obtained pre-injection and within 10 minutes post-injection | Objective evaluation of the number and percentage of subjects with suboptimal echocardiography (based on the definition of inadequate LVEBD; i.e., at least two segments \[combined chamber view\] with an LVEBD score of 0) converted into optimal echocardiography following administration of study drug will be summarized for each reader. |
| Standard 12-lead ECG QT interval | From pre-injection to 24 hours post injection | Standard 12-lead ECG QT interval assessed prior to injection and at 10 and 30 minutes after the end of injection; and at 24 hours after the end of injection |
| Blood Pressure (BP) | From pre-injection to 24 hours post injection | Changes in BP assessed prior to injection and at 5, 10, and 30 minutes the end of after injection; and at 24 hours after the end of injection |
| Heart Rate (HR) | From pre-injection to 24 hours post injection | Changes in HR assessed prior to injection and at 5, 10, and 30 minutes the end of after injection; and at 24 hours after the end of injection |
| SpO2 | From pre-injection to 24 hours post injection | SpO2 assessed by pulse oximetry prior to injection and at 5, 10, and 30 minutes after the end of injection; and at 24 hours after the end of injection |
Countries
Taiwan
Contacts
PRINCIPAL_INVESTIGATORWen-Chung Yu
Taipei Veterans General Hospital, Taiwan
PRINCIPAL_INVESTIGATORChung-Lieh Hung
Mackay Memorial Hospital
PRINCIPAL_INVESTIGATORChih-Hui Chin
Cathay General Hospital
PRINCIPAL_INVESTIGATORHsin-Yueh Liang
China Medical University Hospital
PRINCIPAL_INVESTIGATORNing-I Yang
Chang Gung Memorial Hospital
PRINCIPAL_INVESTIGATORChien-Boon Jong
National Taiwan University Hospital Hsin-Chu Branch
Outcome results
None listed