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临床试验/NCT07762495
NCT07762495尚未招募1 期

Echocardiographic Molecular Imaging for POC Detection of Ischemia

University of Virginia0 个研究点目标入组 80 人开始时间: 2026年9月30日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
尚未招募
入组人数
80
主要终点
Diagnostic accuracy for ACS

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.)

研究组 & 干预措施

Patients with suspected ACS

Experimental

Patients with suspected ACS

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

结局指标

主要结局

Diagnostic accuracy for ACS

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jonathan Lindner, MD

Professor and Vice Chief for Research (CV DIvision)

University of Virginia

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