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

NCT07587294 | Not Yet Recruiting

• 2 other identifiers: WDRY2026-K08682570593
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 7

Brief Summary

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. 1.Does LIFU reduce the frequency and duration of ventricular arrhythmias within 72 hours post-PCI compared to sham ultrasound?
2. 2.Does LIFU improve electrophysiological stability, myocardial injury markers, cardiac function and heart rate variability, and reduce inflammatory markers and sympathetic neurotransmitters?
3. 3.What is the safety profile of LIFU in this population?
4. 4.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
5. 5.Receive 1 assigned ultrasound intervention during PCI, followed by 1 daily intervention for 7 consecutive days postoperatively
6. 6.Undergo 72h continuous ECG monitoring post-PCI, blood sampling at baseline and postoperative days 1, 3, 7, and echocardiography assessment at postoperative day 7
7. 7.Have all adverse events and arrhythmias recorded throughout the study
8. 8.May withdraw voluntarily at any time without affecting routine medical care

Conditions

Acute ST-segment Elevation Myocardial Infarction (Patients Undergoing Emergency PCI)

Keywords

Ultrasound; Stellate ganglion; Neuromodulation; STEMI; Ventricular arrhythmia

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (26)

• IL-1β level

  Baseline and 1, 3, 7 days after PCI

• Norepinephrine level

  Baseline and 1, 3, 7 days after PCI

• Cardiac troponin T (cTnT) level

  Baseline and 1, 3, 7 days after PCI

• SDNN

  72 hours after PCI

• Left ventricular ejection fraction (LVEF)

  7 days after PCI

Study Arms (2)

Ultrasound stimulation group

EXPERIMENTAL

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

Sham group

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: Ultrasound stellate ganglion modulation, LIFU

Ultrasound stimulation group

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.

Also known as: Sham ultrasound neuromodulation, Sham LIFU

Sham group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Renmin Hospital of Wuhan University: lead
• Wuhan Third Hospital: collaborator
• Xiangyang Central Hospital: collaborator
• Wuhan Central Hospital: collaborator
• Taihe Hospital: collaborator
• Jingzhou Central Hospital: collaborator
• Huangshi Central Hospital: collaborator

Study Sites (7)

Huangshi Central Hospital

Huangshi, Hubei, 430060, China

Location

Jingzhou Central Hospital

Jingzhou, Hubei, 430060, China

Location

Shiyan Taihe Hospital

Shiyan, Hubei, 430060, China

Location

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

Location

Wuhan Central Hospital

Wuhan, Hubei, 430060, China

Location

Wuhan Third Hospital

Wuhan, Hubei, 430060, China

Location

Xiangyang Central Hospital

Xiangyang, Hubei, 430060, China

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

Songyun Wang, MD

CONTACT

+86 13871262107; wsy7982@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician & Associate Professor

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 14, 2026
• Study Start: May 5, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 14, 2026

Record last verified: 2026-04

Locations

CN (7)