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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 81
Healthy Volunteers: f
View:

• Participant is willing and able to give informed consent to participate in the study

• Patients who require a cardiac catheterisation procedure as part of their standard medical care

• Good acoustic windows for echocardiography when lying flat on their back

Locations
Other Locations
United Kingdom
King's College Hospital
RECRUITING
London
Contact Information
Primary
Amanda Nio, PhD
amanda.nio@kcl.ac.uk
+44 (0)20 7836 5454
Backup
Kevin O'Gallagher, MBBS, PhD
kevin.o'gallagher@kcl.ac.uk
Time Frame
Start Date: 2026-02
Estimated Completion Date: 2027-03
Participants
Target number of participants: 10
Treatments
Experimental: Contrast echocardiography for intracardiac filling pressures
Sponsors
Collaborators: King's College Hospital NHS Trust
Leads: King's College London

This content was sourced from clinicaltrials.gov