NCT07587294Recruiting
Efficacy and Safety of Ultrasound Modulation of Stellate Ganglion for the Prevention of Ventricular Arrhythmia in Patients With ST-segment Elevation Myocardial Infarction
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
Source: ClinicalTrials.gov · Last updated 21 Aug 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 28 Apr 2026
- Start date
- 15 May 2026
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- Renmin Hospital of Wuhan University
- Diseases
- Coronary artery disease
- NCT number
- NCT07587294
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 15 May 2026 to the primary completion date, 1 Apr 2027
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with concurrent malignant tumors or diseases of vital organs;
- Patients who have participated in other drug or medical device clinical trials within the past 3 months;
Other illness
- Patients with a history of myocardial infarction;
- Patients with a history of cardiac pacemaker or implantable cardioverter-defibrillator (ICD) implantation;
- Patients admitted with frequent ventricular fibrillation or cardiac arrest;
- Patients with skin lesions, infections, or benign or malignant tumors in the left neck;
- Patients with severe cognitive impairment, psychiatric disorders, epilepsy, etc.;
- Patients with active systemic infections;
Lab values
- Patients with severe heart failure (left ventricular ejection fraction \<30%);
- Patients with a history of malignant hematological disorders or renal failure (estimated eGFR \<30 ml/min);
Other
- Patients with severe bradycardia or high-degree atrioventricular block;
- Patients with cardiogenic shock (Killip Class IV);
- Pregnant or breastfeeding women, or women planning to become pregnant during the study;
- Patients who are unable or unwilling to provide informed consent;
- Patients deemed unsuitable for participation in this clinical trial by the investigator.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Huangshi Central Hospital Coordinator of this site? Confirm its status | Huangshi | China | Not yet recruiting |
| Jingzhou Central Hospital Coordinator of this site? Confirm its status | Jingzhou | China | Not yet recruiting |
| Shiyan Taihe Hospital Coordinator of this site? Confirm its status | Shiyan | China | Not yet recruiting |
| Renmin Hospital of Wuhan University Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
| Wuhan Central Hospital Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
| Wuhan Third Hospital Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
| Xiangyang Central Hospital Coordinator of this site? Confirm its status | Xiangyang | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.