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Efficacy and Safety of Ultrasound Modulation of Stellate Ganglion for the Prevention of Ventricular Arrhythmia in Patients With ST-segment Elevation Myocardial Infarction (US-PRAY)

2026年8月19日 更新者：Songyun Wang、Renmin Hospital of Wuhan University

Efficacy and Safety of Ultrasound Modulation of Stellate Ganglion for the Prevention of Ventricular Arrhythmia in Patients With ST-segment Elevation Myocardial Infarction: A Multicenter, Double-blind Randomised Controlled Trial

The goal of this multicenter, double-blind, randomized controlled trial is to evaluate the efficacy and safety of low-intensity focused ultrasound (LIFU) stellate ganglion modulation for preventing ventricular arrhythmias after ST-segment elevation myocardial infarction (STEMI) in patients undergoing percutaneous coronary intervention (PCI).

The main questions it aims to answer are:

  1. Does LIFU reduce the frequency and duration of ventricular arrhythmias within 72 hours post-PCI compared to sham ultrasound?
  2. Does LIFU improve electrophysiological stability, myocardial injury markers, cardiac function and heart rate variability, and reduce inflammatory markers and sympathetic neurotransmitters?
  3. What is the safety profile of LIFU in this population?

100 eligible patients will be randomized 1:1 to receive either active LIFU (2.0W, 1MHz, 50% duty cycle, 30min per session: 1 intra-PCI session + 7 daily post-PCI sessions) plus standard care, or identical sham ultrasound plus standard care. A comprehensive double-blind design (subjects, operators, assessors, statisticians) will be implemented. The study will run from May 2026 to April 2027 at 7 centers in China, led by Renmin Hospital of Wuhan University.

Participants will:

  1. Complete pre-PCI screening and baseline assessments (informed consent, demographic/medical history, physical examination, electrocardiogram, echocardiogram, blood sample collection) within 12 hours of symptom onset
  2. Receive 1 assigned ultrasound intervention during PCI, followed by 1 daily intervention for 7 consecutive days postoperatively
  3. Undergo 72h continuous ECG monitoring post-PCI, blood sampling at baseline and postoperative days 1, 3, 7, and echocardiography assessment at postoperative day 7
  4. Have all adverse events and arrhythmias recorded throughout the study
  5. May withdraw voluntarily at any time without affecting routine medical care

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

100

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Songyun Wang, MD
  • 电话号码：+86 13871262107
  • 邮箱：wsy7982@126.com

学习地点

  • 中国
    • Hubei
      • Huangshi、Hubei、中国、430060
        • 尚未招聘
        • Huangshi Central Hospital
        • 接触：
      • Jingzhou、Hubei、中国、430060
        • 尚未招聘
        • Jingzhou Central Hospital
        • 接触：
      • Shiyan、Hubei、中国、430060
        • 尚未招聘
        • Shiyan Taihe Hospital
        • 接触：
      • Wuhan、Hubei、中国、430060
        • 招聘中
        • Renmin Hospital of Wuhan University
        • 接触：
      • Wuhan、Hubei、中国、430060
        • 尚未招聘
        • Wuhan Third Hospital
        • 接触：
      • Wuhan、Hubei、中国、430060
        • 尚未招聘
        • Wuhan Central Hospital
        • 接触：
      • Xiangyang、Hubei、中国、430060
        • 尚未招聘
        • Xiangyang Central Hospital
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Age between 18 and 80 years (including 18 and 80 years); gender is not restricted;
  2. Agree to be randomly assigned to a treatment strategy and be able to undergo follow-up as required;
  3. Patients with a clinical diagnosis of acute ST-segment elevation myocardial infarction;
  4. Presented within 12 hours of symptom onset and underwent PCI;
  5. Killip functional class I-III;
  6. Agree to participate in this study and voluntarily sign the informed consent form.

Exclusion Criteria:

  1. Patients with a history of myocardial infarction;
  2. Patients with a history of cardiac pacemaker or implantable cardioverter-defibrillator (ICD) implantation;
  3. Patients with severe bradycardia or high-degree atrioventricular block;
  4. Patients with severe heart failure (left ventricular ejection fraction <30%);
  5. Patients with cardiogenic shock (Killip Class IV);
  6. Patients admitted with frequent ventricular fibrillation or cardiac arrest;
  7. Patients with a history of malignant hematological disorders or renal failure (estimated eGFR <30 ml/min);
  8. Patients with skin lesions, infections, or benign or malignant tumors in the left neck;
  9. Pregnant or breastfeeding women, or women planning to become pregnant during the study;
  10. Patients with severe cognitive impairment, psychiatric disorders, epilepsy, etc.;
  11. Patients with concurrent malignant tumors or diseases of vital organs;
  12. Patients with active systemic infections;
  13. Patients who have participated in other drug or medical device clinical trials within the past 3 months;
  14. Patients who are unable or unwilling to provide informed consent;
  15. Patients deemed unsuitable for participation in this clinical trial by the investigator.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Ultrasound stimulation group
Subjects in this arm will receive low-intensity focused ultrasound (LIFU) intervention targeting the left stellate ganglion. The ultrasound probe and skin are disinfected, ultrasound coupling gel is applied, the probe is placed on the skin surface corresponding to the anatomical location of the left stellate ganglion, fixed with a robotic arm, and the instrument is activated. Ultrasound parameters: power 2.0 W, frequency 1 MHz, 50% duty cycle, 30 minutes per session. One session is performed during PCI, followed by once daily for 7 consecutive days postoperatively. All subjects will receive standard cardiovascular care in accordance with 2025 ACC/AHA guidelines, including PCI and indicated medications.
设备：Ultrasound modulation of the left stellate ganglion
Subjects in this arm will receive low-intensity focused ultrasound (LIFU) intervention targeting the left stellate ganglion. The ultrasound probe and skin are disinfected, ultrasound coupling gel is applied, the probe is placed on the skin surface corresponding to the anatomical location of the left stellate ganglion, fixed with a robotic arm, and the instrument is activated. Ultrasound parameters: power 2.0 W, frequency 1 MHz, 50% duty cycle, 30 minutes per session. One session is performed during PCI, followed by once daily for 7 consecutive days postoperatively. All subjects will receive standard cardiovascular care in accordance with 2025 ACC/AHA guidelines, including PCI and indicated medications.
其他名称：
  • 丽芙
  • Ultrasound stellate ganglion modulation
安慰剂比较：Sham group
Subjects in this arm will receive sham ultrasound intervention targeting the left stellate ganglion. The ultrasound probe and skin are disinfected, ultrasound coupling gel is applied, the probe is placed on the skin surface corresponding to the anatomical location of the left stellate ganglion and fixed with a robotic arm. No ultrasound energy is delivered, while the instrument maintains an identical appearance and operational state to the active LIFU arm. Ultrasound parameters: power 2.0 W, frequency 1 MHz, 50% duty cycle, 30 minutes per session. One sham session is performed during PCI, followed by once daily for 7 consecutive days postoperatively. All subjects will receive standard cardiovascular care in accordance with 2025 ACC/AHA guidelines, including PCI and indicated medications.
设备：Sham ultrasound modulation of the left stellate ganglion
Subjects in this arm will receive sham ultrasound intervention targeting the left stellate ganglion. The ultrasound probe and skin are disinfected, ultrasound coupling gel is applied, the probe is placed on the skin surface corresponding to the anatomical location of the left stellate ganglion and fixed with a robotic arm. No ultrasound energy is delivered, while the instrument maintains an identical appearance and operational state to the active LIFU arm. Ultrasound parameters: power 2.0 W, frequency 1 MHz, 50% duty cycle, 30 minutes per session. One sham session is performed during PCI, followed by once daily for 7 consecutive days postoperatively. All subjects will receive standard cardiovascular care in accordance with 2025 ACC/AHA guidelines, including PCI and indicated medications.
其他名称：
  • 深利夫
  • Sham ultrasound neuromodulation

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of ventricular arrhythmias
大体时间：72 hours after PCI
Measurement: Count of ventricular arrhythmia episodes. Measurement device: Wearable Holter monitors.
72 hours after PCI
Duration of ventricular arrhythmias
大体时间：72 hours after PCI
Measurement: Duration of ventricular arrhythmia episodes. Measurement device: Wearable Holter monitors.
72 hours after PCI
NT-proBNP
大体时间：Baseline and 1, 3, 7 days after PCI
Serum N-terminal pro-brain natriuretic peptide concentration; Unit: pg/mL
Baseline and 1, 3, 7 days after PCI

次要结果测量

结果测量
措施说明
大体时间
IL-1β level
大体时间：Baseline and 1, 3, 7 days after PCI
Serum IL-1β concentration; Unit: pg/mL
Baseline and 1, 3, 7 days after PCI
Norepinephrine level
大体时间：Baseline and 1, 3, 7 days after PCI
Serum norepinephrine concentration; Unit: pg/mL
Baseline and 1, 3, 7 days after PCI
Cardiac troponin T (cTnT) level
大体时间：Baseline and 1, 3, 7 days after PCI
Serum cardiac troponin T concentration; Unit: ng/L
Baseline and 1, 3, 7 days after PCI
SDNN
大体时间：72 hours after PCI
Standard deviation of normal-to-normal intervals; Unit: ms Measurement device: Wearable Holter monitors
72 hours after PCI
Left ventricular ejection fraction (LVEF)
大体时间：7 days after PCI
Echocardiographic measurement of left ventricular systolic function; Unit: % Measurement device: Echocardiographic.
7 days after PCI
Alanine aminotransferase (ALT) level
大体时间：Baseline and 7 days after PCI
Serum alanine aminotransferase activity; Unit: U/L
Baseline and 7 days after PCI
Local skin temperature before and after stimulation
大体时间：Baseline (before stimulation) and 30 minutes after stimulation
Baseline (before stimulation) and 30 minutes after stimulation
Serum creatinine level
大体时间：Baseline and 7 days after PCI
Serum creatinine concentration; Unit: μmol/L
Baseline and 7 days after PCI
IL-6 level
大体时间：Baseline and 1, 3, 7 days after PCI
Serum IL-6 concentration; Unit: pg/mL
Baseline and 1, 3, 7 days after PCI
TNF-α level
大体时间：Baseline and 1, 3, 7 days after PCI
Serum TNF-α concentration; Unit: pg/mL
Baseline and 1, 3, 7 days after PCI
Neuropeptide Y level
大体时间：Baseline and 1, 3, 7 days after PCI
Serum neuropeptide Y concentration; Unit: pg/mL
Baseline and 1, 3, 7 days after PCI
SDANN
大体时间：72 hours after PCI
Standard deviation of the averages of normal-to-normal intervals in all 5-minute segments; Unit: ms Measurement device: Wearable Holter monitors
72 hours after PCI
Creatine kinase-MB (CK-MB) level
大体时间：Baseline and 1, 3, 7 days after PCI
Serum creatine kinase-MB activity; Unit: U/L
Baseline and 1, 3, 7 days after PCI
SDANN
大体时间：72 hours after PCI
Standard deviation of the averages of NN intervals in all 5-minute segments; Unit: ms Measurement device: Wearable Holter monitors.
72 hours after PCI
SDNN Index
大体时间：72 hours after PCI
Mean of the standard deviations of all NN intervals for all 5-minute segments ;Unit: ms Measurement device: Wearable Holter monitors.
72 hours after PCI
RMSSD
大体时间：72 hours after PCI

Root mean square of successive differences between normal heartbeats

; Unit: ms Measurement device: Wearable Holter monitors.
72 hours after PCI
pNN50
大体时间：72 hours after PCI

Percentage of successive NN intervals that differ by more than 50 ms

; Unit: % Measurement device: Wearable Holter monitors.
72 hours after PCI
LF power
大体时间：72 hours after PCI
Low frequency power of heart rate variability; Unit: ms² Measurement device: Wearable Holter monitors.
72 hours after PCI
HF power
大体时间：72 hours after PCI
High frequency power of heart rate variability; Unit: ms² Measurement device: Wearable Holter monitors.
72 hours after PCI
LF/HF ratio
大体时间：72 hours after PCI
Ratio of low frequency to high frequency power; Unit: ratio Measurement device: Wearable Holter monitors.
72 hours after PCI
Left ventricular end-systolic volume (LVESV)
大体时间：7 days after PCI
Echocardiographic measurement of left ventricular volume at end-systole; Unit: mL Measurement device: Echocardiographic.
7 days after PCI
Left ventricular end-systolic diameter (LVESD)
大体时间：7 days after PCI
Echocardiographic measurement of left ventricular diameter at end-systole; Unit: mm Measurement device: Echocardiographic.
7 days after PCI
Aspartate aminotransferase (AST) level
大体时间：Baseline and 7 days after PCI
Serum aspartate aminotransferase activity; Unit: U/L
Baseline and 7 days after PCI
Blood urea nitrogen (BUN) level
大体时间：Baseline and 7 days after PCI
Blood urea nitrogen concentration; Unit: mmol/L
Baseline and 7 days after PCI
Estimated glomerular filtration rate (eGFR)
大体时间：Baseline and 7 days after PCI
Estimated glomerular filtration rate calculated using serum creatinine; Unit: mL/min
Baseline and 7 days after PCI
TP
大体时间：72 hours after PCI
Total power of heart rate variability; Unit: ms² Measurement device: Wearable Holter monitors.
72 hours after PCI

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Renmin Hospital of Wuhan University

合作者

Taihe Hospital
Wuhan Central Hospital
Xiangyang Central Hospital
Wuhan Third Hospital
Jingzhou Central Hospital
Huangshi Central Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月15日

初级完成 (估计的)

2027年4月1日

研究完成 (估计的)

2027年4月1日

研究注册日期

首次提交

2026年4月28日

首先提交符合 QC 标准的

2026年5月12日

首次发布 (实际的)

2026年5月14日

研究记录更新

最后更新发布 (实际的)

2026年8月21日

上次提交的符合 QC 标准的更新

2026年8月19日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • WDRY2026-K086
  • 82570593 (其他赠款/资助编号：National Natural Science Foundation of China (NSFC))

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

IPD 计划说明

IPD sharing is currently undecided due to ongoing evaluation of participant privacy safeguards, data security requirements, and multicenter regulatory frameworks.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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