21 and older, any sex, with Cardiac Catheterization or Blood Pressure. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Agreement Between SHAPE and Pressure Catheter MeasurementsPrimary· up to 1 day
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.
Group
Value
95% CI
For Data From Right Ventricle
-0.8
± 0.1
For Data From Left Ventricle
-0.8
± 0.1
Error Between SHAPE and Pressure Catheter MeasurementsPrimary· up to 1 day
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
Group
Value
95% CI
For Data From Left Ventricle - Errors in Mean Diastolic Pressure
5.4
± 7.4
For Data From Left Ventricle - Errors in Minimum Diastolic Pressure
6.6
± 8.3
For Data From Left Ventricle - Errors in End Diastolic Pressure
5.8
± 7.5
For Data From Right Ventricle
1.2
± 1.5
Sponsor's own description
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Thomas Jefferson University
Last refreshed: 29 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03245255.