Echocardiographic Molecular Imaging for POC Detection of Ischemia

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of Virginia

About this trial

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 which can be used 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years of age

Patients with possible or suspected ACS based on clinical criteria (history, ECG, laboratories) and HEART score >3.

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Patients with suspected ACSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Diagnostic accuracy for ACS

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.

Time frame
3 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Virginia

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: