Intracardiac Pressures From Microbubbles Instead of a Catheter: First in Human Study and Signal Calibration

What this Trial Is About

Researchers are investigating whether ultrasound contrast agents can be used to estimate pressures inside the heart in patients suspected of having heart disease. The study aims to determine if there is a strong correlation between the contrast signal and the heart's filling pressures and to develop a calibration method to convert the signal into a pressure measurement in mmHg. This research compares the ultrasound contrast method with the gold standard catheter pressure measurements to evaluate its potential. Participants will receive an ultrasound contrast agent called SonoVue through an intravenous line while undergoing contrast echocardiography, which is an ultrasound scan of the heart with contrast. At the same time, standard echocardiography without contrast will be performed. The study procedures take place on the same day as the participant's standard cardiac catheterisation, where a catheter is guided inside the heart to measure pressures. No additional study visits are required. During the study, participants will be exposed to a small amount of extra ionising radiation to help position the catheter. Researchers will record ultrasound contrast signals simultaneously with catheter pressure measurements to directly compare both methods. They will also collect complementary ultrasound data to create a personalized calibration to estimate pressure from the contrast signal. The primary outcome measured is the correlation between the ultrasound contrast signal and intracardiac pressure, with all assessments completed in about 20 minutes during the catheterisation procedure.

Can Tiny Bubbles Offer an Alternative to Catheters for Assessing Pressures Inside the Heart? Investigating Ultrasound Contrast Agents as Pressure Sensors Against Gold Standard Catheter Pressures in Cardiac Catheterisation Patients.