Acute Coronary SyndromeEarly Phase 1NCT07762495
Echocardiographic Molecular Imaging for POC Detection of Ischemia
A Early Phase 1 study testing Myocardial Contrast Echo (MCE) molecular imaging with Sonazoid in people with Acute Coronary Syndrome, run by University of Virginia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Myocardial Contrast Echo (MCE) molecular imaging with Sonazoid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 30 Jul 2030
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years of age
- Patients with possible or suspected ACS based on clinical criteria (history, ECG, laboratories) and HEART score >3.
Who cannot join
- 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)
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- Pregnancy
- Lactation
- Allergy to ultrasound contrast agents or eggs
- History of autoimmune or inflammatory disease with myocardial involvement (SLE, sarcoidosis, giant cell myocarditis, etc.)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Myocardial Contrast Echo (MCE) molecular imaging with Sonazoid
- Keywords
- acute coronary syndrome, echocardiography, Microbubbles, Myocardial contrast echocardiography
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myocardial Contrast Echo (MCE) molecular imaging with SonazoidDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected ACS | Experimental | Patients with suspected ACS Receives: Diagnostic Test: Myocardial Contrast Echo (MCE) molecular imaging with Sonazoid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jonathan Lindner, MD, University of Virginia
- Investigators
- Jonathan Lindner, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762495
- Sponsor's protocol ID
- HSR 303962
- Other IDs
- R01HL182839
- Status last verified
- Aug 2026
- First submitted
- 8 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing plan not yet approved by UVA IRB
Publications
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.
PubMed 23021335Davidson 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.
PubMed 24774222Mott 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.
PubMed 27318722Davidson 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.
PubMed 34763776
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiographic Molecular Imaging for POC Detection of Ischemia
- ClinicalTrials.gov ID
- NCT07762495
- Acronym / sponsor ID
- HSR 303962
- Conditions
- Acute Coronary Syndrome
- Keywords
- acute coronary syndrome, echocardiography, Microbubbles, Myocardial contrast echocardiography
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jul 2030 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected ACS | Experimental | Diagnostic Test: Myocardial Contrast Echo (MCE) molecular imaging with SonazoidPatients with suspected ACS |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥18 years of age
- Patients with possible or suspected ACS based on clinical criteria (history, ECG, laboratories) and HEART score >3.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myocardial Contrast Echo (MCE) molecular imaging with SonazoidSubjects will undergo point-of-care MCE molecular imaging. Final adjudication of whether subjects had ACS will be made by an expert adjudication Committee | Diagnostic test | Patients with suspected ACS |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Background: PubMed 23021335Davidson 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.
- Background: PubMed 24774222Davidson 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.
- Background: PubMed 27318722Mott 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.
- Background: PubMed 34763776Davidson 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.
- Individual participant dataSharing planned: Undecided. Data sharing plan not yet approved by UVA IRB
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan Lindner, MD principal investigator
University of Virginia
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Myocardial Contrast Echo (MCE) molecular imaging with Sonazoid in people with Acute Coronary Syndrome, run by University of Virginia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan R Lindner, MD (4342979442, jlindner@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy for ACS (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07762495, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.