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NCT Number: NCT07587294

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

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

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Key information

Conditions

Acute ST-segment Elevation Myocardial Infarction (Patients Undergoing Emergency PCI) Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huangshi Central Hospital, Huangshi, Hubei, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • Killip functional class I-III;
  • Agree to participate in this study and voluntarily sign the informed consent form.

Exclusion criteria

  • 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%);
  • Patients with cardiogenic shock (Killip Class IV);
  • Patients admitted with frequent ventricular fibrillation or cardiac arrest;
  • Patients with a history of malignant hematological disorders or renal failure (estimated eGFR <30 ml/min);
  • Patients with skin lesions, infections, or benign or malignant tumors in the left neck;
  • Pregnant or breastfeeding women, or women planning to become pregnant during the study;
  • Patients with severe cognitive impairment, psychiatric disorders, epilepsy, etc.;
  • Patients with concurrent malignant tumors or diseases of vital organs;
  • Patients with active systemic infections;
  • Patients who have participated in other drug or medical device clinical trials within the past 3 months;
  • Patients who are unable or unwilling to provide informed consent;
  • Patients deemed unsuitable for participation in this clinical trial by the investigator.

Treatment and study plan

Ultrasound modulation of the left stellate ganglion

Device

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: Ultrasound stellate ganglion modulation, LIFU

Sham ultrasound modulation of the left stellate ganglion

Device

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 ultrasound neuromodulation, Sham LIFU

Primary outcomes

  1. Number of ventricular arrhythmias

    Time frame: 72 hours after PCI

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

  2. Duration of ventricular arrhythmias

    Time frame: 72 hours after PCI

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

  3. NT-proBNP

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

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

Secondary outcomes

  1. IL-1β level

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

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

  2. Norepinephrine level

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

    Serum norepinephrine concentration; Unit: pg/mL

  3. Cardiac troponin T (cTnT) level

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

    Serum cardiac troponin T concentration; Unit: ng/L

  4. SDNN

    Time frame: 72 hours after PCI

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

  5. Left ventricular ejection fraction (LVEF)

    Time frame: 7 days after PCI

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

  6. Alanine aminotransferase (ALT) level

    Time frame: Baseline and 7 days after PCI

    Serum alanine aminotransferase activity; Unit: U/L

  7. Local skin temperature before and after stimulation

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

  8. Serum creatinine level

    Time frame: Baseline and 7 days after PCI

    Serum creatinine concentration; Unit: μmol/L

  9. IL-6 level

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

    Serum IL-6 concentration; Unit: pg/mL

  10. TNF-α level

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

    Serum TNF-α concentration; Unit: pg/mL

  11. Neuropeptide Y level

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

    Serum neuropeptide Y concentration; Unit: pg/mL

  12. SDANN

    Time frame: 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

  13. Creatine kinase-MB (CK-MB) level

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

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

  14. SDANN

    Time frame: 72 hours after PCI

    Standard deviation of the averages of NN intervals in all 5-minute segments; Unit: ms Measurement device: Wearable Holter monitors.

  15. SDNN Index

    Time frame: 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.

  16. RMSSD

    Time frame: 72 hours after PCI

    Root mean square of successive differences between normal heartbeats

    ; Unit: ms Measurement device: Wearable Holter monitors.

  17. pNN50

    Time frame: 72 hours after PCI

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

    ; Unit: % Measurement device: Wearable Holter monitors.

  18. LF power

    Time frame: 72 hours after PCI

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

  19. HF power

    Time frame: 72 hours after PCI

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

  20. LF/HF ratio

    Time frame: 72 hours after PCI

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

  21. Left ventricular end-systolic volume (LVESV)

    Time frame: 7 days after PCI

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

  22. Left ventricular end-systolic diameter (LVESD)

    Time frame: 7 days after PCI

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

  23. Aspartate aminotransferase (AST) level

    Time frame: Baseline and 7 days after PCI

    Serum aspartate aminotransferase activity; Unit: U/L

  24. Blood urea nitrogen (BUN) level

    Time frame: Baseline and 7 days after PCI

    Blood urea nitrogen concentration; Unit: mmol/L

  25. Estimated glomerular filtration rate (eGFR)

    Time frame: Baseline and 7 days after PCI

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

  26. TP

    Time frame: 72 hours after PCI

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

Study contacts

Contact information is provided by the study sponsor or research team.

Songyun Wang, MD

CONTACT

[email protected]

+86 13871262107

Sponsors and collaborators

Lead sponsor

Renmin Hospital of Wuhan University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: US-PRAY

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 14, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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