A Phase 2 interventional study of Sonazoid in Cardiac Catheterization, Blood Pressure and Heart Ventricles, sponsored by Thomas Jefferson University. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2024-05-29.
Sponsored by Thomas Jefferson University · Phase 2, Interventional, and Diagnostic
This study will use contrast echocardiography to assess the accuracy of a new non-invasive imaging method for subharmonic aided pressure estimation (SHAPE) compared to simultaneously acquired intra-cardiac pressures measured invasively during cardiac catheterization. This study is designed to verify that contrast echocardiography using the SHAPE method, already proven in a canine model and tested in a human pilot study can be used as a surrogate for cardiac catheterization with sufficient accuracy to allow clinical applicability in humans.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 80 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Thomas Jefferson University is the lead sponsor of 384 studies on the registry; 71 are open to participants now.
Of its 44 completed or terminated interventional studies of FDA-regulated products, 20 (45%) have results posted.
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Exclusion Criteria:
48 µl of Sonazoid microbubbles (GE Healthcare, Oslo, Norway) will be co-infused at a rate of 0.024 µl/kg body weight/minute together with a 0.9% sodium chloride solution infused at a rate of at least 2 ml/min.
Drug: Sonazoid
Whenever a patient undergoes cardiac catheterization, which routinely includes intracardiac pressure monitoring using a pressure catheter, as part of their standard clinical care and agrees to participate in the study, we will acquire research data. With Sonazoid infusion, SHAPE algorithm will be initiated to determine optimum acoustic pressure. Then, at the optimum acoustic pressure, SHAPE specific data will be acquired from the cardiac chambers and aorta synchronously with the pressures recorded by the catheter (as a part of the patient's standard of care). After acquiring the ultrasound imaging data, the remainder of the heart catheterization will be completed by the attending cardiologist according to the patients' standard of care.
Agreement Between SHAPE and Pressure Catheter Measurements
The Pearson correlation coefficient was computed between the simultaneously acquired subharmonic signal and pressure catheter data (i.e., waveforms) for each participant. The Pearson correlation coefficient was used for comparing waveforms given the underlying data and pressure values used for comparisons followed a normal distribution. Values reported will be the mean Pearson correlation coefficient values between the subharmonic waveforms and pressure catheter waveforms obtained.
Time frame: up to 1 day
Error Between SHAPE and Pressure Catheter Measurements
Based on the distribution of the differences in cardiac pressure values obtained using the SHAPE technique and the clinical pressure catheter, either a two-tailed paired t test (normal distribution) or Wilcoxon signed rank test (nonnormal distribution) was used to compare the SHAPE technique to the reference standard. Bonferroni corrections were used for multiple comparisons
Time frame: up to 1 day
| Milestone | Sonazoid for Pressure Measurements |
|---|---|
| Started | 80 |
| Completed | 71 |
| Not completed | 9 |
The Pearson correlation coefficient was computed between the simultaneously acquired subharmonic signal and pressure catheter data (i.e., waveforms) for each participant. The Pearson correlation coefficient was used for comparing waveforms given the underlying data and pressure values used for comparisons followed a normal distribution. Values reported will be the mean Pearson correlation coefficient values between the subharmonic waveforms and pressure catheter waveforms obtained.
| Correlation coefficient value | For Data From Right Ventricle | For Data From Left Ventricle |
|---|---|---|
| Agreement Between SHAPE and Pressure Catheter Measurements | -0.8 ± 0.1 | -0.8 ± 0.1 |
Based on the distribution of the differences in cardiac pressure values obtained using the SHAPE technique and the clinical pressure catheter, either a two-tailed paired t test (normal distribution) or Wilcoxon signed rank test (nonnormal distribution) was used to compare the SHAPE technique to the reference standard. Bonferroni corrections were used for multiple comparisons
| mmHg | For Data From Left Ventricle - Errors in Mean Diastolic Pressure | For Data From Left Ventricle - Errors in Minimum Diastolic Pressure | For Data From Left Ventricle - Errors in End Diastolic Pressure | For Data From Right Ventricle |
|---|---|---|---|---|
| Error Between SHAPE and Pressure Catheter Measurements | 5.4 ± 7.4 | 6.6 ± 8.3 | 5.8 ± 7.5 | 1.2 ± 1.5 |
Collected over During data acquisition after Sonazoid infusion (5-10 minutes) and when the patients were observed in the recovery area after the procedure for up to 60 minutes after the procedure.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sonazoid for Pressure Measurements | 0/71 (0%) | 0/71 (0%) | 0/71 (0%) |
| Age, Continuous(years) | Sonazoid for Pressure Measurements |
|---|---|
| Mean | 63 (32 to 82) |
| Sex: Female, Male(Participants) | Sonazoid for Pressure Measurements |
|---|---|
| Female | 31 |
| Male | 49 |
| Race/Ethnicity, Customized(Participants) | Sonazoid for Pressure Measurements |
|---|---|
| White Non Hispanic | 61 |
| Black or African American | 15 |
| Asian | 2 |
| Hispanic or Latino | 1 |
| Other | 1 |
| Region of Enrollment(participants) | Sonazoid for Pressure Measurements |
|---|---|
| United States | 80 |
| Body Mass Index(kg/m^2) | Sonazoid for Pressure Measurements |
|---|---|
| Mean | 30 (15 to 49) |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — This project will generate pressure values in the aorta, and left and right ventricles using the proposed research method (i.e., SHAPE) and using the standard of care (i.e., catheter based pressure values). Additionally peripheral and central pressures will be generated. All of the pressure values will be made available. Further, all ultrasound data obtained for SHAPE measurements will be made available after anonymizing the data-set to remove any patient information
Supporting information: Csr
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