Trial Outcomes & Findings for Noninvasive Real-time Intracardiac Pressure Measurements Using Subharmonic Ultrasound (NCT NCT03245255)

Last Updated: 2024-05-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

80 participants

Primary outcome timeframe

up to 1 day

Results posted on

2024-05-29

Participant Flow

Participant milestones

Participant milestones
Measure	Sonazoid for Pressure Measurements 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. 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.
Overall Study STARTED	80
Overall Study COMPLETED	71
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Noninvasive Real-time Intracardiac Pressure Measurements Using Subharmonic Ultrasound

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sonazoid for Pressure Measurements n=80 Participants 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. 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.
Age, Continuous	63 years n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants
Race/Ethnicity, Customized White Non Hispanic	61 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	15 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants
Region of Enrollment United States	80 participants n=5 Participants
Body Mass Index	30 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: up to 1 day

Population: Data was not acquired in all the enrolled patients due to health concerns during the catheterization procedure, software and/or hardware issues related to the data acquisition process, patient scheduling and/or arrival of emergency cases, and withdrawn consent before the procedure.

Outcome measures

Outcome measures
Measure	For Data From Right Ventricle n=22 Participants For cases in which data was acquired from right ventricle	For Data From Left Ventricle n=25 Participants For cases in which data was acquired from left ventricle	For Data From Left Ventricle - Errors in End Diastolic Pressure Errors in end diastolic pressures between pressures obtained using the pressure catheter and using the SHAPE technique	For Data From Right Ventricle Errors in systolic pressures between pressures obtained using the pressure catheter and using the SHAPE technique
Agreement Between SHAPE and Pressure Catheter Measurements	-0.8 Correlation coefficient value Standard Deviation 0.1	-0.8 Correlation coefficient value Standard Deviation 0.1	—	—

PRIMARY outcome

Timeframe: up to 1 day

Population: LV data were acquired in 25 participants; error calculations were not performed in seven (of 25) participants because the subharmonic signal range was less than the noise threshold of 2.5 dB. RV data were acquired in 22 participants. From this set of 22 participants, the aortic data were not acquired in most, as the participants were scheduled for right heart catheterization only. Due to this, we could only process data from the participants with aortic pressure measurements available.

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

Outcome measures

Outcome measures
Measure	For Data From Right Ventricle n=18 Participants For cases in which data was acquired from right ventricle	For Data From Left Ventricle n=18 Participants For cases in which data was acquired from left ventricle	For Data From Left Ventricle - Errors in End Diastolic Pressure n=18 Participants Errors in end diastolic pressures between pressures obtained using the pressure catheter and using the SHAPE technique	For Data From Right Ventricle n=8 Participants Errors in systolic pressures between pressures obtained using the pressure catheter and using the SHAPE technique
Error Between SHAPE and Pressure Catheter Measurements	5.4 mmHg Standard Deviation 7.4	6.6 mmHg Standard Deviation 8.3	5.8 mmHg Standard Deviation 7.5	1.2 mmHg Standard Deviation 1.5

Adverse Events

Sonazoid for Pressure Measurements

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jaydev Dave

Thomas Jefferson University

Phone: 2158684795

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place