Ischemic Memory Imaging With Myocardial Contrast Echocardiography

August 21, 2018 updated by: Jonathan R. Lindner, MD, Oregon Health and Science University

Ischemic Memory Imaging With MCE

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • OHSU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Normal controls
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).
Drug: Sonazoid
Myocardial contrast echocardiography ischemic memory imaging using intravenous administration of Sonazoid
Experimental: Patients with ACS
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.
Drug: Sonazoid
Myocardial contrast echocardiography ischemic memory imaging using intravenous administration of Sonazoid

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2018

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

December 28, 2016

First Submitted That Met QC Criteria

December 30, 2016

First Posted (Estimate)

January 4, 2017

Study Record Updates

Last Update Posted (Actual)

August 23, 2018

Last Update Submitted That Met QC Criteria

August 21, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00016794

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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