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Ischemic Memory Imaging With Myocardial Contrast Echocardiography

Primary Purpose

Myocardial Ischemia

Status
Unknown status
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sonazoid
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Myocardial Ischemia

Eligibility Criteria

19 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • OHSURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Normal controls

Patients with ACS

Arm 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).

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.

Outcomes

Primary Outcome Measures

Dose optimization
Dose ranging in normal controls to define highest dose of ultrasound contrast agent that does not produce delayed opacification from myocardial retention
Detection of Ischemia

Secondary Outcome Measures

Full Information

First Posted
December 28, 2016
Last Updated
August 21, 2018
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT03009266
Brief Title
Ischemic Memory Imaging With Myocardial Contrast Echocardiography
Official Title
Ischemic Memory Imaging With MCE
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 7, 2018 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Normal controls
Arm Type
Experimental
Arm 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).
Arm Title
Patients with ACS
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Sonazoid
Intervention Description
Myocardial contrast echocardiography ischemic memory imaging using intravenous administration of Sonazoid
Primary Outcome Measure Information:
Title
Dose optimization
Description
Dose ranging in normal controls to define highest dose of ultrasound contrast agent that does not produce delayed opacification from myocardial retention
Time Frame
3 months
Title
Detection of Ischemia
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan R Lindner, MD
Phone
5034949191
Email
lindnerj@ohsu.edu
Facility Information:
Facility Name
OHSU
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan R Lindner, MD
Phone
503-494-8750
Email
lindnerj@ohsu.edu
First Name & Middle Initial & Last Name & Degree
Jonathan R Lindner, MD
First Name & Middle Initial & Last Name & Degree
Brian Davidson, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34763776
Citation
Davidson BP, Hodovan J, Layoun ME, Golwala H, Zahr F, Lindner JR. Echocardiographic Ischemic Memory Molecular Imaging for Point-of-Care Detection of Myocardial Ischemia. J Am Coll Cardiol. 2021 Nov 16;78(20):1990-2000. doi: 10.1016/j.jacc.2021.08.068.
Results Reference
derived

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Ischemic Memory Imaging With Myocardial Contrast Echocardiography

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