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

Renmin Hospital of Wuhan University100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Interventions

Ultrasound modulation of the left stellate ganglionDEVICE

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.

Sham ultrasound modulation of the left stellate ganglionDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (7)

Huangshi Central Hospital

Huangshi, Hubei, China

NOT_YET_RECRUITING

Jingzhou Central Hospital

Jingzhou, Hubei, China

NOT_YET_RECRUITING

Shiyan Taihe Hospital

Shiyan, Hubei, China

NOT_YET_RECRUITING

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

RECRUITING

Wuhan Central Hospital

Wuhan, Hubei, China

NOT_YET_RECRUITING

Wuhan Third Hospital

Wuhan, Hubei, China

NOT_YET_RECRUITING

Xiangyang Central Hospital

Xiangyang, Hubei, China

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

Number of ventricular arrhythmias

Measurement: Count of ventricular arrhythmia episodes. Measurement device: Wearable Holter monitors.

Time frame: 72 hours after PCI

Duration of ventricular arrhythmias

Measurement: Duration of ventricular arrhythmia episodes. Measurement device: Wearable Holter monitors.

Time frame: 72 hours after PCI

NT-proBNP

Serum N-terminal pro-brain natriuretic peptide concentration; Unit: pg/mL

Time frame: Baseline and 1, 3, 7 days after PCI

Secondary Outcomes

IL-1β level

Serum IL-1β concentration; Unit: pg/mL

Time frame: Baseline and 1, 3, 7 days after PCI

Norepinephrine level

Serum norepinephrine concentration; Unit: pg/mL

Time frame: Baseline and 1, 3, 7 days after PCI

Cardiac troponin T (cTnT) level

Serum cardiac troponin T concentration; Unit: ng/L

Time frame: Baseline and 1, 3, 7 days after PCI

SDNN

Standard deviation of normal-to-normal intervals; Unit: ms Measurement device: Wearable Holter monitors

Time frame: 72 hours after PCI

Left ventricular ejection fraction (LVEF)

Echocardiographic measurement of left ventricular systolic function; Unit: % Measurement device: Echocardiographic.

Time frame: 7 days after PCI

Alanine aminotransferase (ALT) level

Serum alanine aminotransferase activity; Unit: U/L

Time frame: Baseline and 7 days after PCI

Local skin temperature before and after stimulation

Time frame: Baseline (before stimulation) and 30 minutes after stimulation

Serum creatinine level

Serum creatinine concentration; Unit: μmol/L

Time frame: Baseline and 7 days after PCI

IL-6 level

Serum IL-6 concentration; Unit: pg/mL

Time frame: Baseline and 1, 3, 7 days after PCI

TNF-α level

Serum TNF-α concentration; Unit: pg/mL

Time frame: Baseline and 1, 3, 7 days after PCI

Neuropeptide Y level

Serum neuropeptide Y concentration; Unit: pg/mL

Time frame: 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

Time frame: 72 hours after PCI

Creatine kinase-MB (CK-MB) level

Serum creatine kinase-MB activity; Unit: U/L

Time frame: 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.

Time frame: 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.

Time frame: 72 hours after PCI

RMSSD

Root mean square of successive differences between normal heartbeats ; Unit: ms Measurement device: Wearable Holter monitors.

Time frame: 72 hours after PCI

pNN50

Percentage of successive NN intervals that differ by more than 50 ms ; Unit: % Measurement device: Wearable Holter monitors.

Time frame: 72 hours after PCI

LF power

Low frequency power of heart rate variability; Unit: ms² Measurement device: Wearable Holter monitors.

Time frame: 72 hours after PCI

HF power

High frequency power of heart rate variability; Unit: ms² Measurement device: Wearable Holter monitors.

Time frame: 72 hours after PCI

LF/HF ratio

Ratio of low frequency to high frequency power; Unit: ratio Measurement device: Wearable Holter monitors.

Time frame: 72 hours after PCI

Left ventricular end-systolic volume (LVESV)

Echocardiographic measurement of left ventricular volume at end-systole; Unit: mL Measurement device: Echocardiographic.

Time frame: 7 days after PCI

Left ventricular end-systolic diameter (LVESD)

Echocardiographic measurement of left ventricular diameter at end-systole; Unit: mm Measurement device: Echocardiographic.

Time frame: 7 days after PCI

Aspartate aminotransferase (AST) level

Serum aspartate aminotransferase activity; Unit: U/L

Time frame: Baseline and 7 days after PCI

Blood urea nitrogen (BUN) level

Blood urea nitrogen concentration; Unit: mmol/L

Time frame: Baseline and 7 days after PCI

Estimated glomerular filtration rate (eGFR)

Estimated glomerular filtration rate calculated using serum creatinine; Unit: mL/min

Time frame: Baseline and 7 days after PCI

Total power of heart rate variability; Unit: ms² Measurement device: Wearable Holter monitors.

Time frame: 72 hours after PCI

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

Overview

Conditions

Interventions

Eligibility

Locations (7)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts