(SIMPI): Sonazoid in Myocardial Perfusion Imaging

Sponsor
London North West Healthcare NHS Trust (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05637333
Collaborator
(none)
10
1
5
2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Contrast Stress Echocardiography

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

Study Type:
Observational
Anticipated Enrollment :
10 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Study Examining if Sonazoid is an Effective Contrast Agent to Identify Myocardial Perfusion
Anticipated Study Start Date :
Dec 15, 2022
Anticipated Primary Completion Date :
Apr 15, 2023
Anticipated Study Completion Date :
May 15, 2023

Outcome Measures

Primary Outcome Measures

  1. To demonstrate if sonazoid gives adequate opacification of the myocardium at low mechanical index using stress echocardiography [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).

  2. To demonstrate if sonazoid gives adequate opacification of the myocardium at intermediate mechanical index using stress echocardiography [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).

Secondary Outcome Measures

  1. Myocardial blood flow reserve assessment for prediction of flow-limiting CAD [1 day]

    Myocardial blood flow will be measured during the scan

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 London North West University Healthcare NHS Trust Harrow Middx United Kingdom HA1 3UJ

Sponsors and Collaborators

  • London North West Healthcare NHS Trust

Investigators

  • Principal Investigator: Roxy Senior, MD, LNWUH NHS Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
London North West Healthcare NHS Trust
ClinicalTrials.gov Identifier:
NCT05637333
Other Study ID Numbers:
  • CRC/2022/004
First Posted:
Dec 5, 2022
Last Update Posted:
Dec 5, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 5, 2022