- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04185246
A Dose Ascending Study to Evaluate the Safety of NH002 as a Contrast Agent in Cardiac Echocardiography
A Multicenter, Open-Label, Dose Ascending Study to Evaluate the Safety of NH002 as a Contrast Agent in Cardiac Echocardiography
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Taipei, Taiwan, 11217
- Taipei Veterans General Hospital
-
Taipei, Taiwan, 10449
- Taipei Mackay Memorial Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female subjects 20 years of age or older
- Ability to understand and the willingness to provide written informed consent
- Suspected of having cardiac disease or undergoing evaluation of cardiac anatomy for congenital heart disease
- Negative pregnancy test within 24 hours of the procedure if subject is a woman of childbearing potential
Exclusion Criteria:
- Known right-to-left, bidirectional, or transient right-to-left cardiac shunt(s)
- Chronic obstructive pulmonary disease
- Ejection fraction at screening or baseline <40%
- 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)
- Clinically significant abnormality in renal and liver function tests (alanine aminotransferase/aspartate aminotransferase >2 × upper limit of normal [ULN]; serum creatinine > 1.5 × ULN)
- Known or suspected hypersensitivity to one or more of the ingredients of NH002, perflutren, or other echocardiographic contrast agent
- Received an investigational compound within 30 days before enrolling in the study
- Received any contrast agent either intravascularly or orally within 48 hours before NH002 administration
- Pregnant or lactating female (conception during the study should be avoided)
- Serious medical or psychiatric illness/condition likely, in the judgment of the investigator, to interfere with compliance to protocol treatment/research
- Clinically unstable cardiopulmonary conditions considered not suitable for participation in the trial, in the judgment of the investigator
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SEQUENTIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Single arm
Subjects will be enrolled with sequential allocation to 1 of 3 cohorts with the following intravenous (IV) doses of NH002: 2.5 µl/kg, 5.0 µl/kg, or 10.0 µl/kg. Each patient will undergo an unenhanced ultrasound examination and a NH002 contrast-enhanced examination on the same day |
NH002 is formulated as a microbubble injectable suspension for intravenous administration.
NH002 requires an activation process prior to use.
Each patient will undergo an unenhanced ultrasound examination and a NH002 contrast-enhanced examination on the same day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
12-lead ECGs
Time Frame: From pre-injection to 60 minutes post injection
|
Standard 12-lead ECGs will be assessed from pre-injection to 60 minutes post-injection for changes in QT/ corrected QT(QTc) interval (in ms) and ECG morphology; each standard 12-lead ECG assessment will be scored as either normal or abnormal
|
From pre-injection to 60 minutes post injection
|
Body temperature
Time Frame: From pre-injection to 120 minutes post injection
|
Monitor for any changes in body temperature (in Celsius degree)
|
From pre-injection to 120 minutes post injection
|
Heart rate
Time Frame: From pre-injection to 120 minutes post injection
|
Monitor for any changes in heart rate (in beats/min)
|
From pre-injection to 120 minutes post injection
|
Respiratory rate
Time Frame: From pre-injection to 120 minutes post injection
|
Monitor for any changes in respiratory rate (in breaths/min)
|
From pre-injection to 120 minutes post injection
|
Blood pressure
Time Frame: From pre-injection to 120 minutes post injection
|
Monitor for any changes in blood pressure (in mmHg)
|
From pre-injection to 120 minutes post injection
|
Thrombin time (TT) and Activated partial thromboplastin time (aPTT)
Time Frame: From pre-injection to 240 minutes post-injection
|
Monitor for any changes in TT and aPTT
|
From pre-injection to 240 minutes post-injection
|
Cardiac troponin I
Time Frame: pre-injection and 240 minutes post-injection
|
Monitor for any changes in Cardiac troponin I
|
pre-injection and 240 minutes post-injection
|
Oxygen saturation by pulse oximetry (SpO2)
Time Frame: From pre-injection to 120 minutes post-injection
|
Monitor for any changes in SpO2
|
From pre-injection to 120 minutes post-injection
|
Rate of any potential adverse allergic reaction
Time Frame: From pre-injection to 240 minutes post-injection
|
Monitor for any potential adverse allergic reaction
|
From pre-injection to 240 minutes post-injection
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Left Ventricular Opacification (LVO)
Time Frame: Image data obtained pre-injection and within 10 minutes post-injection
|
The percentage of subjects with moderate or complete left ventricular opacification (LVO), defined by an LVO grade of 2 (moderate) or 3 (complete), as assessed by the blinded central reader(s). The percentage of subjects with complete LVO, defined by an LVO grade of 3 (complete), as assessed by the blinded central reader(s) |
Image data obtained pre-injection and within 10 minutes post-injection
|
Left Ventricular Endocardial Border Delineation (LVEBD)
Time Frame: Image data obtained pre-injection and within 10 minutes post-injection
|
The change from baseline on the left ventricular endocardial border delineation (LVEBD) score, defined using a standard 12-segment model, as assessed by the blinded central reader(s). The left ventricular (LV) endocardium of the 4- or 2- chamber apical views are divided into 6 segments, with 2 basal, mid- and apical segments in each view. 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 (0-24) is obtained by adding the scores from the 6 individual segments in each of the 2 views. The changes from baseline on LVEBD score of subjects with suboptimal LVEBD at baseline, as defined by 2 or more contiguous segments of 6 segments that cannot be visualized reliably in either the apical 4 and/or the 2-chamber view, as assessed by the blinded central reader(s) |
Image data obtained pre-injection and within 10 minutes post-injection
|
Duration of clinically useful contrast
Time Frame: Image data obtained pre-injection and within 10 minutes post-injection
|
A duration of clinically useful contrast calculated by measuring the time between the disappearance of shadowing effect (useful effect starts) and the time when moderate or full LV enhancement and contrast enhancement are no longer adequate (useful effect ends), as assessed by the blinded central reader(s)
|
Image data obtained pre-injection and within 10 minutes post-injection
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Wen-Chung Yu, Taipei Veterans General Hospital, Taiwan
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NH002-LV
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiac Disease
-
University of British ColumbiaRecruitingSurgery | Cardiac Event | Cardiac Disease | Cardiac Complication | Cardiac Valve Disease | Surgery-ComplicationsCanada
-
Istituto Auxologico ItalianoRecruitingCardiovascular Diseases | Cardiomyopathies | Ischemic Heart Disease | Sudden Cardiac Death Due to Cardiac ArrhythmiaItaly
-
Ostfold University CollegeNot yet recruitingCardiac Arrest | Cardiac Arrhythmia | Cardiac Disease | Cardiac Death
-
Johns Hopkins UniversityNational Human Genome Research Institute (NHGRI)Enrolling by invitationGenetic Counseling | Inherited Cardiac DiseaseUnited States
-
Centro Medico TeknonRecruitingMyocardial Infarction | Ischemic Heart Disease | Ventricular Tachycardia | Magnetic Resonance Imaging | Ventricular Arrythmia | Sudden Cardiac Death | Sudden Cardiac Death Due to Cardiac ArrhythmiaSpain
-
Children's Healthcare of AtlantaTerminated
-
Beijing Chao Yang HospitalBeijing Boren Hospital; Beijing Chuiyangliu HospitalNot yet recruitingM-protein Related Cardiac Disease
-
Maastricht University Medical CenterActive, not recruitingHeart Diseases | Cardiac Conduction DefectNetherlands
-
US Department of Veterans AffairsCompleted
-
Vanderbilt University Medical CenterCompletedCardiac DiseasesUnited States
Clinical Trials on NH002 (Perflutren Lipid Microspheres) Injectable Suspension
-
GE HealthcareICON Clinical ResearchCompletedPulmonary HypertensionUnited States
-
GE HealthcareLaboratory Corporation of AmericaCompletedStudy to Determine Dosage of OPTISON in Children Between ≥9 and <18 Years of Age Weighing ≥20 kgUnited States
-
GE HealthcareTerminatedCarotid Artery DiseaseUnited States
-
University of PennsylvaniaTerminated
-
GE HealthcareCompletedEchocardiographyUnited States
-
Lantheus Medical ImagingCompletedCardiovascular DiseaseUnited States
-
Lantheus Medical ImagingCompletedVentricular Ejection FractionUnited States
-
University of VirginiaNational Institutes of Health (NIH)Unknown
-
Lantheus Medical ImagingCompletedCoronary Artery Disease | Heart DiseaseUnited States
-
Thomas Jefferson UniversityRecruitingProstate CarcinomaUnited States, Netherlands