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

RecruitingNAAges 18 Years - 80 YearsAllRenmin Hospital of Wuhan University
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In plain words

What the trial is, and whether it could suit you

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-PC

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Ultrasound modulation of the left stellate ganglion
  • Sham ultrasound modulation of the left stellate ganglion
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Where

7 sites
Huangshi Central Hospital
Huangshi, China
Jingzhou Central Hospital
Jingzhou, China
Shiyan Taihe Hospital
Shiyan, China
Renmin Hospital of Wuhan University
Wuhan, China
Wuhan Central Hospital
Wuhan, China
Wuhan Third Hospital
Wuhan, China
Xiangyang Central Hospital
Xiangyang, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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