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.

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Другое Contrast Echocardiography
  Simultaneous contrast echocardiography and cardiac catheterisation for intracardiac pressures in the cardiac catheterisation laboratory

Первичные конечные точки

• Correlation between the signal of the ultrasound contrast agent SonoVue and intracardiac pressure measured using a catheter [Срок оценки: 20 minutes]

Вторичные конечные точки (1)

• Intracardiac pressure estimated from the ultrasound signal of SonoVue, converted from dB to mmHg using an ultrasound-based calibration approach [Срок оценки: 20 minutes]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Known previous allergy to SonoVue, used in ultrasound contrast scans
• Known allergy to any of the components of SonoVue microbubbles, for example, sulphur hexafluoride or polyethylene glycol (PEG), also known as macrogol, which is in bowel preparations used during colonoscopy and certain laxatives
• A hole in their heart that lets blood flow from the right side to the left, skipping 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; where severe lung inflammation prevents enough oxygen from reaching the body)
• Current use of the medicine dobutamine (used to treat heart failure), or have been advised not to take dobutamine
• Moderate to severe heart valve disease that could affect the catheter measurements
• Recent acute coronary syndrome or unstable ischaemic cardiac disease, where blood flow to the heart muscle is reduced
• Pregnant or may be pregnant
• Participation in a clinical trial of a medicine within the past four months, to avoid any possible interactions with SonoVue
• Participating in other research that would prolong their cardiac catheterisation procedure, to ensure that the overall process does not become too tiring or burdensome

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Великобритания · 1 центр

• King's College Hospital — London

Публикации

• 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
• 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. PMID 39821267
• 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. PMID 29248652
• 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. PMID 31634833

Идентификаторы

NCT: NCT07416279 · 331447

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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