Ischemic Memory Imaging With Myocardial Contrast Echocardiography

Myocardial Ischemia Clinical Trial

Official title:

Ischemic Memory Imaging With MCE

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03009266
• Other study ID #: IRB00016794
• Status: Recruiting
• Phase: Early Phase 1
• Start date: July 7, 2018
• Est. completion date: December 2019

Study information

• Verified date: August 2018
• Source: Oregon Health and Science University
• Contact: Jonathan R Lindner, MD
• Phone: 5034949191
• Email: lindnerj[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia

Intervention

Drug:
• Sonazoid
Myocardial contrast echocardiography ischemic memory imaging using intravenous administration of Sonazoid

Locations

Country	Name	City	State
United States	OHSU	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose optimization	Dose ranging in normal controls to define highest dose of ultrasound contrast agent that does not produce delayed opacification from myocardial retention	3 months
Primary	Detection of Ischemia		1 year