Clinical trial NCT04185246: A Dose Ascending Study to Evaluate the Safety of NH002 as a Contrast Agent in Cardiac Echocardiography
Official title: A Multicenter, Open-Label, Dose Ascending Study to Evaluate the Safety of NH002 as a Contrast Agent in Cardiac Echocardiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cardiac Disease
Keywords: Echo
Echocardiogram
Cardiac ultrasound
suboptimal
contrast agent
enhancing agent
LVO
LVEBD
Lead sponsor: Trust Bio-sonics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: StatPlus,Inc.
First posted: 2019-12-04
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: NH002 (Perflutren Lipid Microspheres) Injectable Suspension is an ultrasound contrast agent for use in patients with suboptimal echocardiograms to opacify the left ventricular (LV) chamber and to improve the delineation of the LV endocardial border. The primary objective of this study is to evaluate the safety and tolerability of 3 ascending doses of NH002.


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects 20 years of age or older
2. Ability to understand and the willingness to provide written informed consent
3. Suspected of having cardiac disease or undergoing evaluation of cardiac anatomy for congenital heart disease
4. Negative pregnancy test within 24 hours of the procedure if subject is a woman of childbearing potential

Exclusion Criteria:

1. Known right-to-left, bidirectional, or transient right-to-left cardiac shunt(s)
2. Chronic obstructive pulmonary disease
3. Ejection fraction at screening or baseline \<40%
4. Uncontrolled serious ventricular arrhythmias or at high risk for arrhythmias due to prolongation of the QT interval (QT corrected by Fridericia's formula \>450 msec in males and \>470 msec in females)
5. Clinically significant abnormality in renal and liver function tests (alanine aminotransferase/aspartate aminotransferase \>2 × upper limit of normal \[ULN\]; serum creatinine \> 1.5 × ULN)
6. Known or suspected hypersensitivity to one or more of the ingredients of NH002, perflutren, or other echocardiographic contrast agent
7. Received an investigational compound within 30 days before enrolling in the study
8. Received any contrast agent either intravascularly or orally within 48 hours before NH002 administration
9. Pregnant or lactating female (conception during the study should be avoided)
10. Serious medical or psychiatric illness/condition likely, in the judgment of the investigator, to interfere with compliance to protocol treatment/research
11. Clinically unstable cardiopulmonary conditions considered not suitable for participation in the trial, in the judgment of the investigator
12. Uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 200 mmHg or diastolic blood pressure ≥ 110 mmHg) or arterial hypotension (defined as systolic blood pressure ≤ 90 mmHg)

Primary outcomes:
measure: 12-lead ECGs
timeFrame: From pre-injection to 60 minutes post injection
measure: Body Temperature
timeFrame: From pre-injection to 120 minutes post injection
measure: Heart Rate
timeFrame: From pre-injection to 120 minutes post injection
measure: Respiratory Rate
timeFrame: From pre-injection to 120 minutes post injection
measure: Blood Pressure
timeFrame: From pre-injection to 120 minutes post injection
measure: Thrombin Time (TT) and Activated Partial Thromboplastin Time (aPTT)
timeFrame: From pre-injection to 240 minutes post-injection
measure: Cardiac Troponin I
timeFrame: pre-injection and 240 minutes post-injection
measure: Oxygen Saturation by Pulse Oximetry (SpO2)
timeFrame: From pre-injection to 120 minutes post-injection
measure: Rate of Any Potential Adverse Allergic Reaction
timeFrame: From pre-injection to 240 minutes post-injection
measure: Cardiac Troponin T
timeFrame: pre-injection and 240 minutes post-injection
Secondary outcomes:
measure: Left Ventricular Opacification (LVO)
timeFrame: Image data obtained pre-injection and within 10 minutes post-injection
measure: Left Ventricular Endocardial Border Delineation (LVEBD)
timeFrame: Image data obtained pre-injection and within 10 minutes post-injection
measure: Duration of Clinically Useful Contrast
timeFrame: Image data obtained pre-injection and within 10 minutes post-injection
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Wen-Chung Yu
role: PRINCIPAL_INVESTIGATOR
affiliation: Taipei Mackay Memorial Hospital
name: Chung-Lieh Hung
role: PRINCIPAL_INVESTIGATOR
References: