Efficacy and Safety of Ultrasound Modulation of Stellate Ganglion for the Prevention of Ventricular Arrhythmia in Patients With ST-segment Elevation Myocardial Infarction (US-PRAY)
12 de mayo de 2026 actualizado por: Songyun Wang, Renmin Hospital of Wuhan University
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
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:
- Does LIFU reduce the frequency and duration of ventricular arrhythmias within 72 hours post-PCI compared to sham ultrasound?
- Does LIFU improve electrophysiological stability, myocardial injury markers, cardiac function and heart rate variability, and reduce inflammatory markers and sympathetic neurotransmitters?
- 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:
- 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
- Receive 1 assigned ultrasound intervention during PCI, followed by 1 daily intervention for 7 consecutive days postoperatively
- Undergo 72h continuous ECG monitoring post-PCI, blood sampling at baseline and postoperative days 1, 3, 7, and echocardiography assessment at postoperative day 7
- Have all adverse events and arrhythmias recorded throughout the study
- May withdraw voluntarily at any time without affecting routine medical care
Descripción general del estudio
Estado
Aún no reclutando
Tipo de estudio
Intervencionista
Inscripción (Estimado)
100
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Songyun Wang, MD
- Número de teléfono: +86 13871262107
- Correo electrónico: wsy7982@126.com
Ubicaciones de estudio
-
-
Hubei
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Huangshi, Hubei, Porcelana, 430060
- Huangshi Central Hospital
-
Contacto:
- Daoqun Jin, MD
- Número de teléfono: +86 13597680361
- Correo electrónico: edongheart@163.com
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Jingzhou, Hubei, Porcelana, 430060
- Jingzhou Central Hospital
-
Contacto:
- Keping Yang, MD
- Número de teléfono: +86 18107168679
- Correo electrónico: 30461400@qq.com
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Shiyan, Hubei, Porcelana, 430060
- Shiyan Taihe Hospital
-
Contacto:
- Huaqiang Xie, MD
- Número de teléfono: +86 15971876767
- Correo electrónico: xiehqiang@126.com
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Wuhan, Hubei, Porcelana, 430060
- Renmin Hospital of Wuhan University
-
Contacto:
- Songyun Wang, MD
- Número de teléfono: +86 13871262107
- Correo electrónico: wsy7982@126.com
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Wuhan, Hubei, Porcelana, 430060
- Wuhan Central Hospital
-
Contacto:
- Long Wang, MD
- Número de teléfono: +86 15827552859
- Correo electrónico: 319921605@qq.com
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Wuhan, Hubei, Porcelana, 430060
- Wuhan Third Hospital
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Contacto:
- Dongsheng Li, MD
- Número de teléfono: +86 13100680307
- Correo electrónico: lidongsheng693@sina.com
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Xiangyang, Hubei, Porcelana, 430060
- Xiangyang Central Hospital
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Contacto:
- Xiaolin WU, MD
- Número de teléfono: +86 15571179695
- Correo electrónico: 93316363@qq.com
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients with a history of myocardial infarction;
- Patients with a history of cardiac pacemaker or implantable cardioverter-defibrillator (ICD) implantation;
- Patients with severe bradycardia or high-degree atrioventricular block;
- Patients with severe heart failure (left ventricular ejection fraction <30%);
- Patients with cardiogenic shock (Killip Class IV);
- Patients admitted with frequent ventricular fibrillation or cardiac arrest;
- Patients with a history of malignant hematological disorders or renal failure (estimated eGFR <30 ml/min);
- Patients with skin lesions, infections, or benign or malignant tumors in the left neck;
- Pregnant or breastfeeding women, or women planning to become pregnant during the study;
- Patients with severe cognitive impairment, psychiatric disorders, epilepsy, etc.;
- Patients with concurrent malignant tumors or diseases of vital organs;
- Patients with active systemic infections;
- Patients who have participated in other drug or medical device clinical trials within the past 3 months;
- Patients who are unable or unwilling to provide informed consent;
- Patients deemed unsuitable for participation in this clinical trial by the investigator.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Ultrasound stimulation group
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.
|
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.
Otros nombres:
|
|
Comparador de placebos: Sham group
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.
|
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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of ventricular arrhythmias
Periodo de tiempo: 72 hours after PCI
|
Measurement: Count of ventricular arrhythmia episodes.
Measurement device: Wearable Holter monitors.
|
72 hours after PCI
|
|
Duration of ventricular arrhythmias
Periodo de tiempo: 72 hours after PCI
|
Measurement: Duration of ventricular arrhythmia episodes.
Measurement device: Wearable Holter monitors.
|
72 hours after PCI
|
|
NT-proBNP
Periodo de tiempo: Baseline and 1, 3, 7 days after PCI
|
Serum N-terminal pro-brain natriuretic peptide concentration; Unit: pg/mL
|
Baseline and 1, 3, 7 days after PCI
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
IL-1β level
Periodo de tiempo: Baseline and 1, 3, 7 days after PCI
|
Serum IL-1β concentration; Unit: pg/mL
|
Baseline and 1, 3, 7 days after PCI
|
|
Norepinephrine level
Periodo de tiempo: Baseline and 1, 3, 7 days after PCI
|
Serum norepinephrine concentration; Unit: pg/mL
|
Baseline and 1, 3, 7 days after PCI
|
|
Cardiac troponin T (cTnT) level
Periodo de tiempo: Baseline and 1, 3, 7 days after PCI
|
Serum cardiac troponin T concentration; Unit: ng/L
|
Baseline and 1, 3, 7 days after PCI
|
|
SDNN
Periodo de tiempo: 72 hours after PCI
|
Standard deviation of normal-to-normal intervals; Unit: ms Measurement device: Wearable Holter monitors
|
72 hours after PCI
|
|
Left ventricular ejection fraction (LVEF)
Periodo de tiempo: 7 days after PCI
|
Echocardiographic measurement of left ventricular systolic function; Unit: % Measurement device: Echocardiographic.
|
7 days after PCI
|
|
Alanine aminotransferase (ALT) level
Periodo de tiempo: Baseline and 7 days after PCI
|
Serum alanine aminotransferase activity; Unit: U/L
|
Baseline and 7 days after PCI
|
|
Local skin temperature before and after stimulation
Periodo de tiempo: Baseline (before stimulation) and 30 minutes after stimulation
|
Baseline (before stimulation) and 30 minutes after stimulation
|
|
|
Serum creatinine level
Periodo de tiempo: Baseline and 7 days after PCI
|
Serum creatinine concentration; Unit: μmol/L
|
Baseline and 7 days after PCI
|
|
IL-6 level
Periodo de tiempo: Baseline and 1, 3, 7 days after PCI
|
Serum IL-6 concentration; Unit: pg/mL
|
Baseline and 1, 3, 7 days after PCI
|
|
TNF-α level
Periodo de tiempo: Baseline and 1, 3, 7 days after PCI
|
Serum TNF-α concentration; Unit: pg/mL
|
Baseline and 1, 3, 7 days after PCI
|
|
Neuropeptide Y level
Periodo de tiempo: Baseline and 1, 3, 7 days after PCI
|
Serum neuropeptide Y concentration; Unit: pg/mL
|
Baseline and 1, 3, 7 days after PCI
|
|
SDANN
Periodo de tiempo: 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
|
72 hours after PCI
|
|
Creatine kinase-MB (CK-MB) level
Periodo de tiempo: Baseline and 1, 3, 7 days after PCI
|
Serum creatine kinase-MB activity; Unit: U/L
|
Baseline and 1, 3, 7 days after PCI
|
|
SDANN
Periodo de tiempo: 72 hours after PCI
|
Standard deviation of the averages of NN intervals in all 5-minute segments; Unit: ms Measurement device: Wearable Holter monitors.
|
72 hours after PCI
|
|
SDNN Index
Periodo de tiempo: 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.
|
72 hours after PCI
|
|
RMSSD
Periodo de tiempo: 72 hours after PCI
|
Root mean square of successive differences between normal heartbeats ; Unit: ms Measurement device: Wearable Holter monitors. |
72 hours after PCI
|
|
pNN50
Periodo de tiempo: 72 hours after PCI
|
Percentage of successive NN intervals that differ by more than 50 ms ; Unit: % Measurement device: Wearable Holter monitors. |
72 hours after PCI
|
|
LF power
Periodo de tiempo: 72 hours after PCI
|
Low frequency power of heart rate variability; Unit: ms² Measurement device: Wearable Holter monitors.
|
72 hours after PCI
|
|
HF power
Periodo de tiempo: 72 hours after PCI
|
High frequency power of heart rate variability; Unit: ms² Measurement device: Wearable Holter monitors.
|
72 hours after PCI
|
|
LF/HF ratio
Periodo de tiempo: 72 hours after PCI
|
Ratio of low frequency to high frequency power; Unit: ratio Measurement device: Wearable Holter monitors.
|
72 hours after PCI
|
|
Left ventricular end-systolic volume (LVESV)
Periodo de tiempo: 7 days after PCI
|
Echocardiographic measurement of left ventricular volume at end-systole; Unit: mL Measurement device: Echocardiographic.
|
7 days after PCI
|
|
Left ventricular end-systolic diameter (LVESD)
Periodo de tiempo: 7 days after PCI
|
Echocardiographic measurement of left ventricular diameter at end-systole; Unit: mm Measurement device: Echocardiographic.
|
7 days after PCI
|
|
Aspartate aminotransferase (AST) level
Periodo de tiempo: Baseline and 7 days after PCI
|
Serum aspartate aminotransferase activity; Unit: U/L
|
Baseline and 7 days after PCI
|
|
Blood urea nitrogen (BUN) level
Periodo de tiempo: Baseline and 7 days after PCI
|
Blood urea nitrogen concentration; Unit: mmol/L
|
Baseline and 7 days after PCI
|
|
Estimated glomerular filtration rate (eGFR)
Periodo de tiempo: Baseline and 7 days after PCI
|
Estimated glomerular filtration rate calculated using serum creatinine; Unit: mL/min
|
Baseline and 7 days after PCI
|
|
TP
Periodo de tiempo: 72 hours after PCI
|
Total power of heart rate variability; Unit: ms² Measurement device: Wearable Holter monitors.
|
72 hours after PCI
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
5 de mayo de 2026
Finalización primaria (Estimado)
1 de abril de 2027
Finalización del estudio (Estimado)
1 de abril de 2027
Fechas de registro del estudio
Enviado por primera vez
28 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
12 de mayo de 2026
Publicado por primera vez (Actual)
14 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
14 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
12 de mayo de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- WDRY2026-K086
- 82570593 (Otro número de subvención/financiamiento: National Natural Science Foundation of China (NSFC))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan IPD
IPD sharing is currently undecided due to ongoing evaluation of participant privacy safeguards, data security requirements, and multicenter regulatory frameworks.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .