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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 (US-PRAY)

12 de maio de 2026 atualizado 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:

  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

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

100

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Songyun Wang, MD
  • Número de telefone: +86 13871262107
  • E-mail: wsy7982@126.com

Locais de estudo

  • China
    • Hubei
      • Huangshi, Hubei, China, 430060
        • Huangshi Central Hospital
        • Contato:
      • Jingzhou, Hubei, China, 430060
        • Jingzhou Central Hospital
        • Contato:
          • Keping Yang, MD
          • Número de telefone: +86 18107168679
          • E-mail: 30461400@qq.com
      • Shiyan, Hubei, China, 430060
        • Shiyan Taihe Hospital
        • Contato:
      • Wuhan, Hubei, China, 430060
        • Renmin Hospital of Wuhan University
        • Contato:
          • Songyun Wang, MD
          • Número de telefone: +86 13871262107
          • E-mail: wsy7982@126.com
      • Wuhan, Hubei, China, 430060
        • Wuhan Central Hospital
        • Contato:
      • Wuhan, Hubei, China, 430060
        • Wuhan Third Hospital
        • Contato:
      • Xiangyang, Hubei, China, 430060
        • Xiangyang Central Hospital
        • Contato:
          • Xiaolin WU, MD
          • Número de telefone: +86 15571179695
          • E-mail: 93316363@qq.com

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Dispositivo: Ultrasound 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.
Outros nomes:
  • LIFU
  • Ultrasound stellate ganglion modulation
Comparador de Placebo: 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.
Dispositivo: Sham 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.
Outros nomes:
  • Simulação de LIFU
  • Sham ultrasound neuromodulation

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Number of ventricular arrhythmias
Prazo: 72 hours after PCI
Measurement: Count of ventricular arrhythmia episodes. Measurement device: Wearable Holter monitors.
72 hours after PCI
Duration of ventricular arrhythmias
Prazo: 72 hours after PCI
Measurement: Duration of ventricular arrhythmia episodes. Measurement device: Wearable Holter monitors.
72 hours after PCI
NT-proBNP
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
IL-1β level
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 7 days after PCI
Echocardiographic measurement of left ventricular systolic function; Unit: % Measurement device: Echocardiographic.
7 days after PCI
Alanine aminotransferase (ALT) level
Prazo: 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
Prazo: Baseline (before stimulation) and 30 minutes after stimulation
Baseline (before stimulation) and 30 minutes after stimulation
Serum creatinine level
Prazo: Baseline and 7 days after PCI
Serum creatinine concentration; Unit: μmol/L
Baseline and 7 days after PCI
IL-6 level
Prazo: 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
Prazo: 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
Prazo: Baseline and 1, 3, 7 days after PCI
Serum neuropeptide Y concentration; Unit: pg/mL
Baseline and 1, 3, 7 days after PCI
SDANN
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 72 hours after PCI
Low frequency power of heart rate variability; Unit: ms² Measurement device: Wearable Holter monitors.
72 hours after PCI
HF power
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: Baseline and 7 days after PCI
Serum aspartate aminotransferase activity; Unit: U/L
Baseline and 7 days after PCI
Blood urea nitrogen (BUN) level
Prazo: Baseline and 7 days after PCI
Blood urea nitrogen concentration; Unit: mmol/L
Baseline and 7 days after PCI
Estimated glomerular filtration rate (eGFR)
Prazo: Baseline and 7 days after PCI
Estimated glomerular filtration rate calculated using serum creatinine; Unit: mL/min
Baseline and 7 days after PCI
TP
Prazo: 72 hours after PCI
Total power of heart rate variability; Unit: ms² Measurement device: Wearable Holter monitors.
72 hours after PCI

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Renmin Hospital of Wuhan University

Colaboradores

Taihe Hospital
Wuhan Central Hospital
Xiangyang Central Hospital
Wuhan Third Hospital
Jingzhou Central Hospital
Huangshi Central Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

5 de maio de 2026

Conclusão Primária (Estimado)

1 de abril de 2027

Conclusão do estudo (Estimado)

1 de abril de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

28 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

12 de maio de 2026

Primeira postagem (Real)

14 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

14 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

12 de maio de 2026

Última verificação

1 de abril de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • WDRY2026-K086
  • 82570593 (Número de outro subsídio/financiamento: National Natural Science Foundation of China (NSFC))

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Descrição do plano IPD

IPD sharing is currently undecided due to ongoing evaluation of participant privacy safeguards, data security requirements, and multicenter regulatory frameworks.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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