Ischemic Memory Imaging With Myocardial Contrast Echocardiography

Early Phase 1

• Conditions: Myocardial Ischemia
• Interventions: Drug: Sonazoid

• Registration Number: NCT03009266
• Lead Sponsor: Oregon Health and Science University

Brief Summary

The overall aim of this study is to determine whether non-invasive imaging with myocardial contrast echocardiography using can provide information on the presence and spatial extent of recent myocardial ischemia by non-invasive echocardiographic imaging.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-28
• Study First Submitted QC: 2016-12-30
• Study First Posted: 2017-01-04
• Study Start: 2018-07-07
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-21
• Last Update Posted: 2018-08-23
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Normal control individuals

Exclusion Criteria

• History of cardiovascular disease (coronary artery disease, MI, peripheral artery disease)
• allergy to eggs or ultrasound contrast agents
• known or detected right to left shunt
• presence of a wall motion abnormality
• pregnancy

ACS GROUP

Inclusion Criteria:

• Patients with diagnosis of acute coronary syndrome with either unstable angina or non-ST-elevation MI
• Referred for primary percutaneous intervention
• At least 1 high risk features (ST changes, positive troponin, wall motion abnormality)

Exclusion Criteria:

• allergy to eggs or ultrasound contrast agents
• hemodynamic instability or shock
• known or detected right to left shunt
• pregnancy
• multivessel CAD requiring multivessel PCI

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal controls	Sonazoid	Normal controls who will undergo dose-ranging studies to determine the optimal dose of phosphatidylserine-containing microbubbles that does not produce delayed myocardial opacification on myocardial contrast echocardiography (MCE).
Patients with ACS	Sonazoid	Subjects with ACS who have undergone primary percutaneous intervention in whom MCE with phosphatidylserine-containing microbubbles will be performed to determine whether the risk area can be detected and spatially defined.

Primary Outcome Measures

Name	Time	Method
Detection of Ischemia	1 year
Dose optimization	3 months	Dose ranging in normal controls to define highest dose of ultrasound contrast agent that does not produce delayed opacification from myocardial retention

Trial Locations

Locations (1)

OHSU; 🇺🇸 Portland, Oregon, United States