TrialReader


Ischemic Memory Imaging With Myocardial Contrast Echocardiography

NCT03009266 — Early Phase 1, Unknown, 40 participants, Oregon Health and Science University

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

Ischemic Memory Imaging With MCE

RegistryNCT03009266
StatusUnknown
PhaseEarly Phase 1
Study typeInterventional; non randomized, parallel, masking: none, diagnostic
Enrollment40 (Estimated)
SponsorOregon Health and Science University (Other)
ConditionsMyocardial Ischemia
InterventionsSonazoid (Drug)
Datesstart 2018-07-07, primary completion 2019-12-01 (estimated), completion 2019-12-01 (estimated), first posted 2017-01-04, last updated 2018-08-23
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Myocardial Ischemia All trials of Sonazoid

-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.

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
Normal controlsExperimentalDrug: SonazoidNormal 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 ACSExperimentalDrug: SonazoidSubjects 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.
  • Sonazoid (Drug): Myocardial contrast echocardiography ischemic memory imaging using intravenous administration of Sonazoid

+Outcome measures

Primary outcomes

  • Dose optimization [3 months]: 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 [1 year]

+Eligibility

Sex: All, ages: 19 Years to 90 Years, accepts 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

+Locations (1)

FacilityCityCountryStatus
OHSUPortland, OregonUnited StatesRecruiting

+Publications

  • Results publication: 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 34763776

My Notes