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
Age between 18 and 80 years (including 18 and 80 years); gender is not restricted;
Agree to be randomly assigned to a treatment strategy and be able to undergo follow-up as required;
Patients with a clinical diagnosis of acute ST-segment elevation myocardial infarction;
Presented within 12 hours of symptom onset and underwent PCI;
Patients with a history of myocardial infarction;
Patients with a history of cardiac pacemaker or implantable cardioverter-defibrillator (ICD) implantation;
Patients with severe bradycardia or high-degree atrioventricular block;
Patients with severe heart failure (left ventricular ejection fraction <30%);
Parallel
Ultrasound modulation of the left stellate ganglion
DeviceSubjects 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.
Sham ultrasound modulation of the left stellate ganglion
DeviceSubjects 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.
Number of ventricular arrhythmias
Measurement: Count of ventricular arrhythmia episodes. Measurement device: Wearable Holter monitors.
Duration of ventricular arrhythmias
Measurement: Duration of ventricular arrhythmia episodes. Measurement device: Wearable Holter monitors.
NT-proBNP
Serum N-terminal pro-brain natriuretic peptide concentration; Unit: pg/mL
IL-1β level
Serum IL-1β concentration; Unit: pg/mL
Norepinephrine level
Serum norepinephrine concentration; Unit: pg/mL
Cardiac troponin T (cTnT) level
Serum cardiac troponin T concentration; Unit: ng/L
SDNN
Standard deviation of normal-to-normal intervals; Unit: ms Measurement device: Wearable Holter monitors
Click on the lead sponsor to view all of their trials.
Renmin Hospital of Wuhan University
Lead sponsor
Wuhan Third Hospital
Collaborator
Xiangyang Central Hospital
Collaborator
Wuhan Central Hospital
Collaborator
Taihe Hospital
Collaborator
Jingzhou Central Hospital
Collaborator
Huangshi Central Hospital
Collaborator
