Ultrasound treatment to calm neck nerves after a heart attack to stop dangerous rhythms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, double-blind, randomized trial enrolling patients with acute STEMI undergoing PCI to see if targeted ultrasound modulation of the left stellate ganglion can reduce ventricular arrhythmias within 72 hours after PCI. Participants are randomized to active ultrasound treatment versus sham, in addition to standard care. The intervention includes one intra-PCI session plus seven daily post-PCI sessions, with outcomes spanning arrhythmia burden, electrophysiological stability, biomarkers of myocardial injury, cardiac function, heart rate variability, inflammatory markers, and safety. Enrollment aims for 100 participants with 1:1 randomization. The study is led by Renmin Hospital of Wuhan University with several regional centers in Hubei province.

Why it matters

Who can join: the full rules

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.

Where it's running

• Renmin Hospital of Wuhan University
  Wuhan, Hubei, China Recruiting
• Huangshi Central Hospital
  Huangshi, Hubei, China Not yet recruiting
• Jingzhou Central Hospital
  Jingzhou, Hubei, China Not yet recruiting
• Shiyan Taihe Hospital
  Shiyan, Hubei, China Not yet recruiting
• Wuhan Central Hospital
  Wuhan, Hubei, China Not yet recruiting
• Wuhan Third Hospital
  Wuhan, Hubei, China Not yet recruiting

Study contacts

• Study coordinator: Songyun Wang, MD
• Email: wsy7982@126.com
• Phone: +86 13871262107

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.