Acute ST-segment Elevation Myocardial Infarction (Patients Undergoing Emergency PCI)
Conditions
Keywords
Ultrasound, Stellate ganglion, Neuromodulation, STEMI, Ventricular arrhythmia
Brief summary
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
Interventions
DEVICEUltrasound modulation of the left stellate ganglion
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.
DEVICESham ultrasound modulation of the left stellate ganglion
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.
Sponsors
Renmin Hospital of Wuhan University
Wuhan Third Hospital
Xiangyang Central Hospital
Wuhan Central Hospital
Taihe Hospital
Jingzhou Central Hospital
Huangshi Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of ventricular arrhythmias | 72 hours after PCI | Measurement: Count of ventricular arrhythmia episodes. Measurement device: Wearable Holter monitors. |
| Duration of ventricular arrhythmias | 72 hours after PCI | Measurement: Duration of ventricular arrhythmia episodes. Measurement device: Wearable Holter monitors. |
| NT-proBNP | Baseline and 1, 3, 7 days after PCI | Serum N-terminal pro-brain natriuretic peptide concentration; Unit: pg/mL |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IL-1β level | Baseline and 1, 3, 7 days after PCI | Serum IL-1β concentration; Unit: pg/mL |
| Norepinephrine level | Baseline and 1, 3, 7 days after PCI | Serum norepinephrine concentration; Unit: pg/mL |
| Cardiac troponin T (cTnT) level | Baseline and 1, 3, 7 days after PCI | Serum cardiac troponin T concentration; Unit: ng/L |
| SDNN | 72 hours after PCI | Standard deviation of normal-to-normal intervals; Unit: ms Measurement device: Wearable Holter monitors |
| Left ventricular ejection fraction (LVEF) | 7 days after PCI | Echocardiographic measurement of left ventricular systolic function; Unit: % Measurement device: Echocardiographic. |
| Alanine aminotransferase (ALT) level | Baseline and 7 days after PCI | Serum alanine aminotransferase activity; Unit: U/L |
| Local skin temperature before and after stimulation | Baseline (before stimulation) and 30 minutes after stimulation | — |
| Serum creatinine level | Baseline and 7 days after PCI | Serum creatinine concentration; Unit: μmol/L |
| IL-6 level | Baseline and 1, 3, 7 days after PCI | Serum IL-6 concentration; Unit: pg/mL |
| TNF-α level | Baseline and 1, 3, 7 days after PCI | Serum TNF-α concentration; Unit: pg/mL |
| Neuropeptide Y level | Baseline and 1, 3, 7 days after PCI | Serum neuropeptide Y concentration; Unit: pg/mL |
| SDANN | 72 hours after PCI | Standard deviation of the averages of normal-to-normal intervals in all 5-minute segments; Unit: ms Measurement device: Wearable Holter monitors |
| Creatine kinase-MB (CK-MB) level | Baseline and 1, 3, 7 days after PCI | Serum creatine kinase-MB activity; Unit: U/L |
| SDNN Index | 72 hours after PCI | Mean of the standard deviations of all NN intervals for all 5-minute segments ;Unit: ms Measurement device: Wearable Holter monitors. |
| RMSSD | 72 hours after PCI | Root mean square of successive differences between normal heartbeats ; Unit: ms Measurement device: Wearable Holter monitors. |
| pNN50 | 72 hours after PCI | Percentage of successive NN intervals that differ by more than 50 ms ; Unit: % Measurement device: Wearable Holter monitors. |
| LF power | 72 hours after PCI | Low frequency power of heart rate variability; Unit: ms² Measurement device: Wearable Holter monitors. |
| HF power | 72 hours after PCI | High frequency power of heart rate variability; Unit: ms² Measurement device: Wearable Holter monitors. |
| LF/HF ratio | 72 hours after PCI | Ratio of low frequency to high frequency power; Unit: ratio Measurement device: Wearable Holter monitors. |
| Left ventricular end-systolic volume (LVESV) | 7 days after PCI | Echocardiographic measurement of left ventricular volume at end-systole; Unit: mL Measurement device: Echocardiographic. |
| Left ventricular end-systolic diameter (LVESD) | 7 days after PCI | Echocardiographic measurement of left ventricular diameter at end-systole; Unit: mm Measurement device: Echocardiographic. |
| Aspartate aminotransferase (AST) level | Baseline and 7 days after PCI | Serum aspartate aminotransferase activity; Unit: U/L |
| Blood urea nitrogen (BUN) level | Baseline and 7 days after PCI | Blood urea nitrogen concentration; Unit: mmol/L |
| Estimated glomerular filtration rate (eGFR) | Baseline and 7 days after PCI | Estimated glomerular filtration rate calculated using serum creatinine; Unit: mL/min |
| TP | 72 hours after PCI | Total power of heart rate variability; Unit: ms² Measurement device: Wearable Holter monitors. |
Countries
China
Contacts
CONTACTSongyun Wang, MD
Outcome results
None listed