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Echocardiographic Molecular Imaging for POC Detection of Ischemia

NCT07762495 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-08-13

No results posted yet for this study

Summary

Molecular imaging with myocardial contrast echocardiography (MCE) relies on the non-invasive detection of targeted microbubbles (MBs) or other acoustically active agents. The confinement of MBs to the vascular compartment makes them ideal for assessing acute inflammatory responses involving endothelial cell activation and immune cell recruitment. A construct for imaging inflammation and endothelial activation can be achieved by altering amphipathic lipid shell composition in MBs. Specifically, incorporation of phosphatidylserine (PS) into the shell of MBs promotes adhesion to activated leukocytes and endothelial cells in order to detect ischemia, whether active or resolved. Our first in human studies to use myocardial contrast echocardiography (MCE) to detect inflammation secondary to ischemia was performed with a PS-containing MB contrast agent (Sonazoid) where we studied patients with known acute coronary syndrome (ACS) who had just undergone acute percutaneous coronary intervention. In this study, we will conduct a proof-of-concept clinical trial where MCE molecular imaging with Sonazoid will be performed in 80 patients with suspected rather than known ACS. We will test whether MCE ischemic memory imaging with MB-PS can diagnose or exclude ACS, and assess risk based on spatial extent of signal enhancement.

Conditions

  • Acute Coronary Syndrome

Interventions

DIAGNOSTIC_TEST

Myocardial Contrast Echo (MCE) molecular imaging with Sonazoid

Subjects will undergo point-of-care MCE molecular imaging. Final adjudication of whether subjects had ACS will be made by an expert adjudication Committee

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • University of Virginia

    lead OTHER

Principal Investigators

  • Jonathan Lindner, MD · University of Virginia

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2030-06-30
Completion
2030-07-30
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07762495 on ClinicalTrials.gov