Ischemic Memory Imaging With Myocardial Contrast Echocardiography

Oregon Health & Science University (OHSU)

Status and phase: Unknown; Early Phase 1

Conditions: Myocardial Ischemia

Treatments: Drug: Sonazoid

Study type: Interventional

Funder types: Other

Identifiers

NCT03009266

IRB00016794

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 19 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

NORMAL CONTROL GROUP

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Normal controls

Experimental group

Description:

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).

Treatment:

Drug: Sonazoid

Patients with ACS

Experimental group

Description:

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.

Treatment:

Drug: Sonazoid