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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 14
- 主要终点
- Number of ventricular arrhythmias
研究概览
简要总结
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:
- Does LIFU reduce the frequency and duration of ventricular arrhythmias within 72 hours post-PCI compared to sham ultrasound?
- Does LIFU improve electrophysiological stability, myocardial injury markers, cardiac function and heart rate variability, and reduce inflammatory markers and sympathetic neurotransmitters?
- 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:
- 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
- Receive 1 assigned ultrasound intervention during PCI, followed by 1 daily intervention for 7 consecutive days postoperatively
- Undergo 72h continuous ECG monitoring post-PCI, blood sampling at baseline and postoperative days 1, 3, 7, and echocardiography assessment at postoperative day 7
- Have all adverse events and arrhythmias recorded throughout the study
- May withdraw voluntarily at any time without affecting routine medical care
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Ultrasound modulation of the left stellate ganglion (Device)
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.
干预措施: Sham ultrasound modulation of the left stellate ganglion (Device)
结局指标
主要结局
Number of ventricular arrhythmias
时间窗: 72 hours after PCI
Measurement: Count of ventricular arrhythmia episodes. Measurement device: Wearable Holter monitors.
Duration of ventricular arrhythmias
时间窗: 72 hours after PCI
Measurement: Duration of ventricular arrhythmia episodes. Measurement device: Wearable Holter monitors.
NT-proBNP
时间窗: Baseline and 1, 3, 7 days after PCI
Serum N-terminal pro-brain natriuretic peptide concentration; Unit: pg/mL
次要结局
- 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)
- Alanine aminotransferase (ALT) level(Baseline and 7 days after PCI)
- Local skin temperature before and after stimulation(Baseline (before stimulation) and 30 minutes after stimulation)
- Serum creatinine level(Baseline and 7 days after PCI)
- IL-6 level(Baseline and 1, 3, 7 days after PCI)
- TNF-α level(Baseline and 1, 3, 7 days after PCI)
- Neuropeptide Y level(Baseline and 1, 3, 7 days after PCI)
- SDANN(72 hours after PCI)
- Creatine kinase-MB (CK-MB) level(Baseline and 1, 3, 7 days after PCI)
- SDNN Index(72 hours after PCI)
- RMSSD(72 hours after PCI)
- pNN50(72 hours after PCI)
- LF power(72 hours after PCI)
- HF power(72 hours after PCI)
- LF/HF ratio(72 hours after PCI)
- Left ventricular end-systolic volume (LVESV)(7 days after PCI)
- Left ventricular end-systolic diameter (LVESD)(7 days after PCI)
- Aspartate aminotransferase (AST) level(Baseline and 7 days after PCI)
- Blood urea nitrogen (BUN) level(Baseline and 7 days after PCI)
- Estimated glomerular filtration rate (eGFR)(Baseline and 7 days after PCI)
- TP(72 hours after PCI)
研究者
Songyun Wang
Associate Chief Physician & Associate Professor
Renmin Hospital of Wuhan University