Ischemic Memory Imaging With Myocardial Contrast Echocardiography
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Jul 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 28, 2016
CompletedFirst Posted
Study publicly available on registry
January 4, 2017
CompletedStudy Start
First participant enrolled
July 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedAugust 23, 2018
August 1, 2018
1.4 years
December 28, 2016
August 21, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
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
Detection of Ischemia
1 year
Study Arms (2)
Normal controls
EXPERIMENTALNormal 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
EXPERIMENTALSubjects 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.
Interventions
Myocardial contrast echocardiography ischemic memory imaging using intravenous administration of Sonazoid
Eligibility Criteria
You may qualify if:
- Normal control individuals
You may not qualify if:
- 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
- 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)
- allergy to eggs or ultrasound contrast agents
- hemodynamic instability or shock
- known or detected right to left shunt
- pregnancy
- multivessel CAD requiring multivessel PCI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
OHSU
Portland, Oregon, 97239, United States
Related Publications (1)
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.
PMID: 34763776DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 28, 2016
First Posted
January 4, 2017
Study Start
July 7, 2018
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
August 23, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share