Sonazoid in Myocardial Perfusion Imaging

Myocardial Ischemia Clinical Trial

— (SIMPI)  

Official title:

Study Examining if Sonazoid is an Effective Contrast Agent to Identify Myocardial Perfusion

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05637333
• Other study ID #: CRC/2022/004
• Status: Withdrawn
• Start date: December 15, 2022
• Est. completion date: May 15, 2023

Study information

• Verified date: March 2023
• Source: London North West Healthcare NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. This study will look at the feasibility of using sonozoid in this way.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 15, 2023
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Positive and normal Clinical SE

• Able to provide informed consent

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Diagnostic Imaging
• Ischemia
• Myocardial Ischemia

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
United Kingdom	London North West University Healthcare NHS Trust	Harrow	Middx

Sponsors (1)

Lead Sponsor	Collaborator
London North West Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1 day
Primary	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).	1 day
Secondary	Myocardial blood flow reserve assessment for prediction of flow-limiting CAD	Myocardial blood flow will be measured during the scan	1 day