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NCT Number: NCT07762495

Echocardiographic Molecular Imaging for POC Detection of Ischemia

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years of age
  • Patients with possible or suspected ACS based on clinical criteria (history, ECG, laboratories) and HEART score >3.

Exclusion criteria

  • Cardiogenic shock
  • Inability to obtain consent
  • Severe heart failure (NYHA class IV)
  • Mechanical complication of MI (ischemic VSD, papillary muscle rupture, ventricular free wall rupture)
  • Ongoing life-threatening arrhythmias
  • Neutropenia (<1,500/mm3)
  • Pregnancy
  • Lactation
  • Allergy to ultrasound contrast agents or eggs
  • History of autoimmune or inflammatory disease with myocardial involvement (SLE, sarcoidosis, giant cell myocarditis, etc.)

Treatment and study plan

Myocardial Contrast Echo (MCE) molecular imaging with Sonazoid

Diagnostic Test

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

Primary outcomes

  1. Diagnostic accuracy for ACS

    Time frame: 3 months

    Analysis (quanitative and qualitative) of MCE molecular imaging with Sonazoid will be made blinded to all clinical data. Final adjudication of presence/absence of ACS will be made by an adjudication committee 3 months later.

Study contacts

Contact information is provided by the study sponsor or research team.

Jonathan R Lindner, MD

CONTACT

[email protected]

4342979442

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

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

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Aug 13, 2026
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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