Echocardiographic Molecular Imaging for POC Detection of Ischemia

NCT07762495 | Not Yet Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: HSR 303962R01HL182839
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Acute Coronary Syndrome

Keywords

acute coronary syndrome; echocardiography; Microbubbles; Myocardial contrast echocardiography

Outcome Measures

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.

  3 months

Study Arms (1)

Patients with suspected ACS

EXPERIMENTAL

Patients with suspected ACS

Diagnostic Test: Myocardial Contrast Echo (MCE) molecular imaging with Sonazoid

Interventions

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

Patients with suspected ACS

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Virginia: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Related Publications (4)

• Davidson BP, Kaufmann BA, Belcik JT, Xie A, Qi Y, Lindner JR. Detection of antecedent myocardial ischemia with multiselectin molecular imaging. J Am Coll Cardiol. 2012 Oct 23;60(17):1690-7. doi: 10.1016/j.jacc.2012.07.027. Epub 2012 Sep 26.

  PMID: 23021335 BACKGROUND

• Davidson BP, Chadderdon SM, Belcik JT, Gupta S, Lindner JR. Ischemic memory imaging in nonhuman primates with echocardiographic molecular imaging of selectin expression. J Am Soc Echocardiogr. 2014 Jul;27(7):786-793.e2. doi: 10.1016/j.echo.2014.03.013. Epub 2014 Apr 26.

  PMID: 24774222 BACKGROUND

• Mott B, Packwood W, Xie A, Belcik JT, Taylor RP, Zhao Y, Davidson BP, Lindner JR. Echocardiographic Ischemic Memory Imaging Through Complement-Mediated Vascular Adhesion of Phosphatidylserine-Containing Microbubbles. JACC Cardiovasc Imaging. 2016 Aug;9(8):937-46. doi: 10.1016/j.jcmg.2015.11.031. Epub 2016 Jun 15.

  PMID: 27318722 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Molecular Imaging

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Molecular Probe Techniques; Investigative Techniques

Study Officials

• Jonathan Lindner, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan R Lindner, MD

CONTACT

4342979442; jlindner@virginia.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Vice Chief for Research (CV DIvision)

Study Record Dates

• First Submitted: August 8, 2026
• First Posted: August 13, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): July 30, 2030
• Last Updated: August 20, 2026

Record last verified: 2026-08