Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2022-12-15
2023-05-15
Brief Summary
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Detailed Description
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Using ultrasound at low acoustic power (low/intermediate MI) causes the microbubbles to oscillate resulting in giving off non-linear signals which are different from tissues which gives off linear signals.
The first contrast agents were used in 1968. Since then the technology has been refined and now the microbubbles are more stable and consist of an inert gas encapsulated in a lipid or albumin shell. These microbubbles remain intact in the systemic circulation because of their small size can transit through the pulmonary circulation.
The indication for myocardial perfusion imaging is when vasodilator stress like Dipyridamole is performed. Vasodilators do not readily induce wall motion abnormalities but cause perfusion defects to occur which allows detection of CAD. Myocardial perfusion imaging is also indicated during treadmill or dobutamine stress when suspicion of CAD is high as it is more sensitive than wall motion for the detection of CAD.
Myocardial perfusion imaging looks at a uniformity of contrast appearance in the myocardium, following a continuous microbubble infusion. If there is decreased perfusion, the appearance of contrast will be delayed and the opacification will not be uniform.
The advantage of Sonazoid over the other frequently used contrast agents (Sonovue, Luminity, Optison) is that the microbubbles are more robust, allowing for a higher MI setting to be used during scanning. The higher MI setting enhances higher intensity bubble signal with improved spatial and temporal resolution which improves image quality and diagnostic accuracy.
This study is not looking for diagnosis in patients, which will be done according to standard of care. It is to evaluate whether it is possible to assess myocardial perfusion using the contrast agent Sonazoid.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Contrast Stress Echocardiography
Dipyridamole will be infused at 0.56mg/kg of body weight over 4mins. After 2 minutes, if the patient has tolerated the infusion well, a further 0.28mg/kg will be infused over 2 minutes. Tolerance will be determined by the absence of 1) myocardial ischaemia (significant chest pain with ECG ST depression or T wave inversion or wall motion abnormality on ECHO) 2) a significant drop in blood pressure 3) significant arrhythmia and 4) intolerable symptoms. One minute after completion of Dipyridamole infusion Sonazoid will be infused at the same rate as was used during acquisition of the rest images. After 45 seconds when steady state is reached, the ultrasound images will be acquired as stated below in contrast imaging. If the Dipyridamole is not well tolerated by one minute after the 0.56mg/kg infusion, we will move straight to the infusion of Sonazoid with no extra 0.28mg/kg infusion.
Eligibility Criteria
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Inclusion Criteria
* Able to provide informed consent
Exclusion Criteria
* Allergy to Perfluorobutane
* Egg allergy
* Patients with right to left arteriovenous cardiac or pulmonary shunt
* Unstable heart disease
* Serious pulmonary disease
* Pregnancy or lactation Women of child bearing potential (defined as not chemically or surgically sterilised or post menopausal)
18 Years
ALL
No
Sponsors
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London North West Healthcare NHS Trust
OTHER
Responsible Party
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Principal Investigators
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Roxy Senior, MD
Role: PRINCIPAL_INVESTIGATOR
LNWUH NHS Trust
Locations
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London North West University Healthcare NHS Trust
Harrow, Middx, United Kingdom
Countries
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Other Identifiers
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CRC/2022/004
Identifier Type: -
Identifier Source: org_study_id
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