King's College Hospital
London, SE5 9RS, United Kingdom
Location status: Recruiting
NCT Number: NCT07416279
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:
* Is there a strong correlation between the contrast signal and filling pressures inside the heart? * What is the calibration approach to convert the contrast signal from dB to a measure of pressure in mmHg?
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:
* Be exposed to a small amount of additional ionising radiation to guide a catheter in position inside the heart for reference pressures * Receive an ultrasound contrast agent at the clinically recommended dose and in line with clinical guidelines, via an intravenous line in their arm * Undergo contrast echocardiography - ultrasound scan of their heart with contrast * Undergo standard echocardiography - ultrasound scan of their heart without contrast
Interested in participating?
Request Info21 year–81 year
All sexes
Interventional
Not applicable
London, SE5 9RS, United Kingdom
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Simultaneous contrast echocardiography and cardiac catheterisation for intracardiac pressures in the cardiac catheterisation laboratory
Other names: Standard echocardiography, High frame rate contrast echocardiography
Time frame: 20 minutes
The ultrasound signal of SonoVue at the subharmonic frequency will be compared with left ventricular filling pressures measured using a high-fidelity catheter.
Time frame: 20 minutes
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.
Contact information is provided by the study sponsor or research team.
Amanda Nio, PhD
CONTACT
Kevin O'Gallagher, MBBS, PhD
CONTACT
King's College London
Other
Intracardiac Pressures From Microbubbles Instead of a Catheter: First in Human Study and Signal Calibration
Acronym: SonoHeart
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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