Cardiac Catheterization, Blood Pressure, Heart Ventricles, Echocardiography, Heart Failure
Conditions
Keywords
pressure measurements, blood pressure, contrast echocardiography, ventricular pressures, catheterization
Brief summary
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.
Interventions
DRUGSonazoid
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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
GE Healthcare
Thomas Jefferson University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be scheduled for cardiac catheterization procedure. * Be at least 18 years of age. * Be medically stable. * If a female of child-bearing potential, must have a negative pregnancy test. * Be conscious and able to comply with study procedures. * Have signed Informed Consent to participate in the study.
Exclusion criteria
* Clinically unstable patients, e.g., those who are clinically in decompensated heart failure or having active chest pain or presenting for admission with an unstable anginal syndrome * Patients in whom introduction of a catheter into the left ventricle is contraindicated or would potentially be dangerous, e.g., patients with active ventricular arrhythmias or with significant aortic valve stenosis where crossing the aortic valve may be difficult and not clinically necessary * Females who are pregnant or nursing. * Patients not scheduled for cardiac catheterization procedure. * Patients who have received an investigational drug in the 30 days before, or will receive one within 72 h after, study drug administration. * Patients currently on chemotherapy or with other primary cancers requiring treatment. * Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. * Patients with a history of anaphylactic allergy to eggs or egg products, manifested by one or more of the following symptoms: generalised urticaria, difficulty in breathing, swelling of the mouth and throat, hypotension, or shock. (Subjects with nonanaphylactic allergies to eggs or egg products may be enrolled in the study, but must be watched carefully for 1 h following the administration of SONAZOID). * Patients with congenital heart defects. * Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli. * Patients with respiratory distress syndrome or a contraindication to pharmacological vasodilator stress agents. * Patients with thrombosis within the hepatic, portal, or mesenteric veins.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement Between SHAPE and Pressure Catheter Measurements | 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. |
| Error Between SHAPE and Pressure Catheter Measurements | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 80 |
| Total | 80 |
Baseline characteristics
| Characteristic | Sonazoid for Pressure Measurements |
|---|---|
| Age, Continuous | 63 years |
| Body Mass Index | 30 kg/m^2 |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 15 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White Non Hispanic | 61 Participants |
| Region of Enrollment United States | 80 participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 71 |
| other Total, other adverse events | 0 / 71 |
| serious Total, serious adverse events | 0 / 71 |
Outcome results
Primary
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
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| For Data From Right Ventricle | Agreement Between SHAPE and Pressure Catheter Measurements | -0.8 Correlation coefficient value | Standard Deviation 0.1 |
| For Data From Left Ventricle | Agreement Between SHAPE and Pressure Catheter Measurements | -0.8 Correlation coefficient value | Standard Deviation 0.1 |
Primary
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
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.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| For Data From Right Ventricle | Error Between SHAPE and Pressure Catheter Measurements | 5.4 mmHg | Standard Deviation 7.4 |
| For Data From Left Ventricle | Error Between SHAPE and Pressure Catheter Measurements | 6.6 mmHg | Standard Deviation 8.3 |
| For Data From Left Ventricle - Errors in End Diastolic Pressure | Error Between SHAPE and Pressure Catheter Measurements | 5.8 mmHg | Standard Deviation 7.5 |
| For Data From Right Ventricle | Error Between SHAPE and Pressure Catheter Measurements | 1.2 mmHg | Standard Deviation 1.5 |