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| Name | Class |
|---|---|
| King's College Hospital NHS Trust | OTHER |
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The goal of this clinical trial is to investigate if ultrasound contrast agents can be used to estimate filling pressures inside the heart in patients with suspected heart disease. The main questions it aims to answer are:
Researchers will compare the contrast signal with reference pressures measured using a catheter to see if it can be used to quantify filling pressures inside the heart.
Participants will:
This study will record ultrasound contrast signals simultaneously with gold standard catheter pressure measurements inside the heart, to enable a direct comparison between the two methods. Complementary ultrasound data will be used to develop a personalised calibration solution to convert the contrast signal in dB to estimated pressure in mmHg. All study procedures will be completed on the same day as the participant's standard of care cardiac catheterisation and no additional study visits will be required.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contrast echocardiography for intracardiac filling pressures | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contrast Echocardiography | Other | Simultaneous contrast echocardiography and cardiac catheterisation for intracardiac pressures in the cardiac catheterisation laboratory |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between the signal of the ultrasound contrast agent SonoVue and intracardiac pressure measured using a catheter | The ultrasound signal of SonoVue at the subharmonic frequency will be compared with left ventricular filling pressures measured using a high-fidelity catheter. | 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Intracardiac pressure estimated from the ultrasound signal of SonoVue, converted from dB to mmHg using an ultrasound-based calibration approach | The signal of ultrasound contrast agents has to be calibrated to convert it from dB to mmHg for pressure. Ultrasound-based approaches involving standard echocardiography and high frame rate contrast echocardiography will be investigated as potential calibration approaches in this study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amanda Nio, PhD | Contact | +44 (0)20 7836 5454 | amanda.nio@kcl.ac.uk | |
| Kevin O'Gallagher, MBBS, PhD | Contact | kevin.o'gallagher@kcl.ac.uk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King's College Hospital | Recruiting | London | SE5 9RS | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Dockerill C, Faraci A, Christensen-Jeffries K, Alastruey J, Rajani R, Lamata P and Nio AQX (2021). SonoVue microbubbles as ultrasound pressure sensors in a dynamic flow phantom. IEEE International Ultrasonics Symposium. doi: 10.1109/IUS52206.2021.9593833 | ||
| 39821267 | Background | Smiseth OA, Fernandes JF, Ohte N, Wakami K, Donal E, Remme EW, Lamata P. Imaging-based method to quantify left ventricular diastolic pressures. Eur Heart J Cardiovasc Imaging. 2025 Jun 30;26(7):1184-1194. doi: 10.1093/ehjci/jeaf017. | |
| 29248652 |
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De-identified data towards any publications and conference papers will be made publicly available on an online open access repository (e.g. Figshare) after the research output is accepted.
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|
| 20 minutes |
| Background |
| Toulemonde MEG, Corbett R, Papadopoulou V, Chahal N, Li Y, Leow CH, Cosgrove DO, Eckersley RJ, Duncan N, Senior R, Tang MX. High Frame-Rate Contrast Echocardiography: In-Human Demonstration. JACC Cardiovasc Imaging. 2018 Jun;11(6):923-924. doi: 10.1016/j.jcmg.2017.09.011. Epub 2017 Dec 13. No abstract available. |
| 31634833 | Background | Nio AQX, Faraci A, Christensen-Jeffries K, Raymond JL, Monaghan MJ, Fuster D, Forsberg F, Eckersley RJ, Lamata P. Optimal Control of SonoVue Microbubbles to Estimate Hydrostatic Pressure. IEEE Trans Ultrason Ferroelectr Freq Control. 2020 Mar;67(3):557-567. doi: 10.1109/TUFFC.2019.2948759. Epub 2019 Oct 21. |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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