Acute ST-segment elevation myocardial infarction (patients undergoing emergency PCI)
Conditions
Interventions
Sham group:Sham ultrasound intervention + standard treatment
Ultrasound stimulation group:Low-intensity focused ultrasound modulation of the stellate ganglion + standard treatment
Sponsors
Renmin Hospital of Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and duration of ventricular arrhythmias;NT-proBNP; | — |
Secondary
| Measure | Time frame |
|---|---|
| Local skin temperature before and after stimulation;Peak time of myocardial injury markers (cTnT, CK-MB);Inflammatory markers (IL-1ß, IL-6, TNF-a) and sympathetic neurotransmitters (NE, NPY);Heart rate viability;Liver and kidney function (ALT, AST, Crea, BUN, eGFR);Cardiac function; | — |
Countries
China
Contacts
Public ContactSongyun Wang
Renmin Hospital of Wuhan University
Outcome results
None listed