Ischemic Memory Imaging With Myocardial Contrast Echocardiography

NCT ID: NCT03009266

Last Updated: 2018-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-07

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Myocardial Ischemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Sonazoid

Intervention Type DRUG

Myocardial contrast echocardiography ischemic memory imaging using intravenous administration of Sonazoid

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.

Group Type EXPERIMENTAL

Sonazoid

Intervention Type DRUG

Myocardial contrast echocardiography ischemic memory imaging using intravenous administration of Sonazoid

Interventions

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Sonazoid

Myocardial contrast echocardiography ischemic memory imaging using intravenous administration of Sonazoid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Normal control individuals


* 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

* 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


* allergy to eggs or ultrasound contrast agents
* hemodynamic instability or shock
* known or detected right to left shunt
* pregnancy
* multivessel CAD requiring multivessel PCI
Minimum Eligible Age

19 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Jonathan R. Lindner, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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OHSU

Portland, Oregon, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jonathan R Lindner, MD

Role: CONTACT

5034949191

Facility Contacts

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Jonathan R Lindner, MD

Role: primary

503-494-8750

References

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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.

Reference Type DERIVED
PMID: 34763776 (View on PubMed)

Other Identifiers

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IRB00016794

Identifier Type: -

Identifier Source: org_study_id

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