Sonazoid in Myocardial Perfusion Imaging

NCT05637333 | Withdrawn

• 1 other identifier: CRC/2022/004
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Diagnostic Imaging; Myocardial Ischemia

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Myocardial blood flow reserve assessment for prediction of flow-limiting CAD

  1 day

Interventions

Contrast Stress Echocardiography DIAGNOSTIC_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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• Positive and normal Clinical SE
• Able to provide informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• London North West Healthcare NHS Trust: lead

Study Sites (1)

London North West University Healthcare NHS Trust

Harrow, Middx, HA1 3UJ, United Kingdom

Location

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Roxy Senior, MD

  LNWUH NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: December 5, 2022
• Study Start: December 15, 2022
• Primary Completion: April 15, 2023
• Study Completion: May 15, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)