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)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Acute ST-segment Elevation Myocardial Infarction (Patients Undergoing Emergency PCI)
• Intervention / Treatment: Device: Ultrasound modulation of the left stellate ganglion; Device: Sham ultrasound modulation of the left stellate ganglion

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Songyun Wang, MD; Phone Number: +86 13871262107; Email: wsy7982@126.com

Study Locations

• China
  • Hubei
    • Huangshi, Hubei, China, 430060
      • Huangshi Central Hospital
      • Contact: Daoqun Jin, MD; Phone Number: +86 13597680361; Email: edongheart@163.com
    • Jingzhou, Hubei, China, 430060
      • Jingzhou Central Hospital
      • Contact: Keping Yang, MD; Phone Number: +86 18107168679; Email: 30461400@qq.com
    • Shiyan, Hubei, China, 430060
      • Shiyan Taihe Hospital
      • Contact: Huaqiang Xie, MD; Phone Number: +86 15971876767; Email: xiehqiang@126.com
    • Wuhan, Hubei, China, 430060
      • Renmin Hospital of Wuhan University
      • Contact: Songyun Wang, MD; Phone Number: +86 13871262107; Email: wsy7982@126.com
    • Wuhan, Hubei, China, 430060
      • Wuhan Central Hospital
      • Contact: Long Wang, MD; Phone Number: +86 15827552859; Email: 319921605@qq.com
    • Wuhan, Hubei, China, 430060
      • Wuhan Third Hospital
      • Contact: Dongsheng Li, MD; Phone Number: +86 13100680307; Email: lidongsheng693@sina.com
    • Xiangyang, Hubei, China, 430060
      • Xiangyang Central Hospital
      • Contact: Xiaolin WU, MD; Phone Number: +86 15571179695; Email: 93316363@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.; Other Names: LIFU; Ultrasound stellate ganglion modulation
Placebo Comparator: 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.	Device: 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.; Other Names: Sham LIFU; Sham ultrasound neuromodulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of ventricular arrhythmias	Measurement: Count of ventricular arrhythmia episodes. Measurement device: Wearable Holter monitors.	72 hours after PCI
Duration of ventricular arrhythmias	Measurement: Duration of ventricular arrhythmia episodes. Measurement device: Wearable Holter monitors.	72 hours after PCI
NT-proBNP	Serum N-terminal pro-brain natriuretic peptide concentration; Unit: pg/mL	Baseline and 1, 3, 7 days after PCI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IL-1β level	Serum IL-1β concentration; Unit: pg/mL	Baseline and 1, 3, 7 days after PCI
Norepinephrine level	Serum norepinephrine concentration; Unit: pg/mL	Baseline and 1, 3, 7 days after PCI
Cardiac troponin T (cTnT) level	Serum cardiac troponin T concentration; Unit: ng/L	Baseline and 1, 3, 7 days after PCI
SDNN	Standard deviation of normal-to-normal intervals; Unit: ms Measurement device: Wearable Holter monitors	72 hours after PCI
Left ventricular ejection fraction (LVEF)	Echocardiographic measurement of left ventricular systolic function; Unit: % Measurement device: Echocardiographic.	7 days after PCI
Alanine aminotransferase (ALT) level	Serum alanine aminotransferase activity; Unit: U/L	Baseline and 7 days after PCI
Local skin temperature before and after stimulation		Baseline (before stimulation) and 30 minutes after stimulation
Serum creatinine level	Serum creatinine concentration; Unit: μmol/L	Baseline and 7 days after PCI
IL-6 level	Serum IL-6 concentration; Unit: pg/mL	Baseline and 1, 3, 7 days after PCI
TNF-α level	Serum TNF-α concentration; Unit: pg/mL	Baseline and 1, 3, 7 days after PCI
Neuropeptide Y level	Serum neuropeptide Y concentration; Unit: pg/mL	Baseline and 1, 3, 7 days after PCI
SDANN	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	Serum creatine kinase-MB activity; Unit: U/L	Baseline and 1, 3, 7 days after PCI
SDANN	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	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	Root mean square of successive differences between normal heartbeats ; Unit: ms Measurement device: Wearable Holter monitors.	72 hours after PCI
pNN50	Percentage of successive NN intervals that differ by more than 50 ms ; Unit: % Measurement device: Wearable Holter monitors.	72 hours after PCI
LF power	Low frequency power of heart rate variability; Unit: ms² Measurement device: Wearable Holter monitors.	72 hours after PCI
HF power	High frequency power of heart rate variability; Unit: ms² Measurement device: Wearable Holter monitors.	72 hours after PCI
LF/HF ratio	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)	Echocardiographic measurement of left ventricular volume at end-systole; Unit: mL Measurement device: Echocardiographic.	7 days after PCI
Left ventricular end-systolic diameter (LVESD)	Echocardiographic measurement of left ventricular diameter at end-systole; Unit: mm Measurement device: Echocardiographic.	7 days after PCI
Aspartate aminotransferase (AST) level	Serum aspartate aminotransferase activity; Unit: U/L	Baseline and 7 days after PCI
Blood urea nitrogen (BUN) level	Blood urea nitrogen concentration; Unit: mmol/L	Baseline and 7 days after PCI
Estimated glomerular filtration rate (eGFR)	Estimated glomerular filtration rate calculated using serum creatinine; Unit: mL/min	Baseline and 7 days after PCI
TP	Total power of heart rate variability; Unit: ms² Measurement device: Wearable Holter monitors.	72 hours after PCI

Collaborators and Investigators

• Sponsor: Renmin Hospital of Wuhan University
• Collaborators: Taihe Hospital; Wuhan Central Hospital; Xiangyang Central Hospital; Wuhan Third Hospital; Jingzhou Central Hospital; Huangshi Central Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 5, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: April 28, 2026
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Ultrasound; Neuromodulation; STEMI; Ventricular arrhythmia; Stellate ganglion
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Myocardial Infarction; Ischemia; Pathological Conditions, Signs and Symptoms; ST Elevation Myocardial Infarction
• Other Study ID Numbers: WDRY2026-K086; 82570593 (Other Grant/Funding Number: National Natural Science Foundation of China (NSFC))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD sharing is currently undecided due to ongoing evaluation of participant privacy safeguards, data security requirements, and multicenter regulatory frameworks.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No