Actively Recruiting
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.
Led by King's College London · Updated on 2026-02-18
10
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
Sponsors
K
King's College London
Lead Sponsor
K
King's College Hospital NHS Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Known previous allergy to SonoVue, used in ultrasound contrast scans
- Known allergy to any components of SonoVue microbubbles, such as sulphur hexafluoride or polyethylene glycol (PEG)
- A hole in the heart that lets blood flow from the right side to the left, bypassing the lungs
- Very high blood pressure in the arteries of the lungs (severe pulmonary hypertension)
- Uncontrolled high blood pressure (hypertension)
- Adult respiratory distress syndrome (ARDS)
- Current use of dobutamine or advised not to take it
- Moderate to severe heart valve disease affecting catheter measurements
- Recent acute coronary syndrome or unstable ischemic cardiac disease
- Pregnant or possibly pregnant
- Participation in a medicine clinical trial within the past four months
- Participation in other research that would prolong the cardiac catheterisation procedure
AI-Screening
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Trial Site Locations
Total: 1 location
1
King's College Hospital
London, United Kingdom, SE5 9RS
Actively Recruiting
Research Team
A
Amanda Nio, PhD
CONTACT
K
Kevin O'Gallagher, MBBS, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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