Diagnostic Imaging(SIMPI)NCT05637333
Sonazoid in Myocardial Perfusion Imaging
An observational study of Diagnostic Imaging and Myocardial Ischemia, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
Currently, Sonazoid is mainly used for imaging liver lesions by assessing perfusion characteristics. However, the ultrasound technology is the same as for cardiac imaging and the stability of the microbubbles will potentially aid the detection of myocardial perfusion defects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diagnostic Imaging, Myocardial Ischemia
- What is being tested?
- Contrast Stress Echocardiography
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Dec 2022to 15 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 10 patients will be identified for this proof of concept study. Patients who have already had a positive clinical stress echo scan will be approached about participating in this study
Who may be able to join
- Positive and normal Clinical SE
- Able to provide informed consent
Who cannot join
- Unable / unwilling to give informed consent
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
London North West University Healthcare NHS Trust
Harrow, Middx, HA1 3UJ
About this study
Official title: Study Examining if Sonazoid is an Effective Contrast Agent to Identify Myocardial Perfusion
Currently, Sonazoid is mainly used for imaging liver lesions by assessing perfusion characteristics. However, the ultrasound technology is the same as for cardiac imaging and the stability of the microbubbles will potentially aid the detection of myocardial perfusion defects. This study will look at the feasibility of using sonozoid in this way.
Read the detailed description
Ultrasound contrast agents are gas-filled microbubbles that enhance the visualisation of cardiac structures, function and blood flow. Myocardial contrast echocardiography enables us to visualise myocardial perfusion and provides incremental information for diagnosis of coronary artery disease (CAD) and prognosis beyond wall motion assessment .
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
- Diagnostic Imaging, Myocardial Ischemia
- Being tested
- Contrast Stress Echocardiography
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast Stress EchocardiographyDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate if sonazoid gives adequate opacification of the myocardium at low mechanical index using stress echocardiography
Contrast Stress echocardiography (SE) using sonazoid will be used to predict if patients with very low probability of CAD have flow-limiting coronary stenosis>70% in any major coronary artery branches in patients with previous significant (>2 contiguous segments) inducible ischemia on stress echocardiography (SE).
Measured: 1 day
To demonstrate if sonazoid gives adequate opacification of the myocardium at intermediate mechanical index using stress echocardiography
Contrast Stress echocardiography (SE) using sonazoid will be used to predict if patients with very low probability of CAD have flow-limiting coronary stenosis>70% in any major coronary artery branches in patients with previous significant (>2 contiguous segments) inducible ischemia on stress echocardiography (SE).
Measured: 1 day
Secondary outcomes (1)
Myocardial blood flow reserve assessment for prediction of flow-limiting CAD
Myocardial blood flow will be measured during the scan
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start15 Dec 2022 (estimated)
- Primary completion15 Apr 2023 (estimated)
- Study completion15 May 2023 (estimated)
Why it stopped: Study classed as CTIMP
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnostic ImagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- London North West Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roxy Senior, MD, Principal investigator, LNWUH NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637333
- Sponsor's protocol ID
- CRC/2022/004
- Acronym
- (SIMPI)
- Status last verified
- Mar 2023
- First submitted
- 12 Oct 2022
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Examining if Sonazoid is an Effective Contrast Agent to Identify Myocardial Perfusion
- ClinicalTrials.gov ID
- NCT05637333
- Acronym / sponsor ID
- (SIMPI) / CRC/2022/004
- Conditions
- Diagnostic Imaging, Myocardial Ischemia
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study classed as CTIMP
- Enrolment
- 0 participants (actual)
- Lead sponsor
- London North West Healthcare NHS TrustUniversity, hospital or other
- Study start
- 15 Dec 2022 (estimated)
- Primary completion
- 15 Apr 2023 (estimated)
- Study completion
- 15 May 2023 (estimated)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently, Sonazoid is mainly used for imaging liver lesions by assessing perfusion characteristics. However, the ultrasound technology is the same as for cardiac imaging and the stability of the microbubbles will potentially aid the detection of myocardial perfusion defects. This study will look at the feasibility of using sonozoid in this way.
Detailed description
Ultrasound contrast agents are gas-filled microbubbles that enhance the visualisation of cardiac structures, function and blood flow. Myocardial contrast echocardiography enables us to visualise myocardial perfusion and provides incremental information for diagnosis of coronary artery disease (CAD) and prognosis beyond wall motion assessment .
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 10 patients will be identified for this proof of concept study. Patients who have already had a positive clinical stress echo scan will be approached about participating in this study
Key inclusion criteria (2 listed)
- Positive and normal Clinical SE
- Able to provide informed consent
Key exclusion criteria (7 listed)
- Unable / unwilling to give informed consent
- Allergy to Perfluorobutane
- Egg allergy
- Patients with right to left arteriovenous cardiac or pulmonary shunt
- Unstable heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast Stress EchocardiographyDipyridamole 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. | Diagnostic test | – |
Primary outcome
To demonstrate if sonazoid gives adequate opacification of the myocardium at low mechanical index using stress echocardiography
Time frame: 1 day
Contrast Stress echocardiography (SE) using sonazoid will be used to predict if patients with very low probability of CAD have flow-limiting coronary stenosis>70% in any major coronary artery branches in patients with previous significant (>2 contiguous segments) inducible ischemia on stress echocardiography (SE).
To demonstrate if sonazoid gives adequate opacification of the myocardium at intermediate mechanical index using stress echocardiography
Time frame: 1 day
Contrast Stress echocardiography (SE) using sonazoid will be used to predict if patients with very low probability of CAD have flow-limiting coronary stenosis>70% in any major coronary artery branches in patients with previous significant (>2 contiguous segments) inducible ischemia on stress echocardiography (SE).
1 secondary outcome
Myocardial blood flow reserve assessment for prediction of flow-limiting CAD
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roxy Senior, MD principal investigator
LNWUH NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diagnostic Imaging and Myocardial Ischemia, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate if sonazoid gives adequate opacification of the myocardium at low mechanical index using stress echocardiography (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.