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 mai 2026 mis à jour par: 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
Aperçu de l'étude
Statut
Pas encore de recrutement
Type d'étude
Interventionnel
Inscription (Estimé)
100
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Songyun Wang, MD
- Numéro de téléphone: +86 13871262107
- E-mail: wsy7982@126.com
Lieux d'étude
-
-
Hubei
-
Huangshi, Hubei, Chine, 430060
- Huangshi Central Hospital
-
Contact:
- Daoqun Jin, MD
- Numéro de téléphone: +86 13597680361
- E-mail: edongheart@163.com
-
Jingzhou, Hubei, Chine, 430060
- Jingzhou Central Hospital
-
Contact:
- Keping Yang, MD
- Numéro de téléphone: +86 18107168679
- E-mail: 30461400@qq.com
-
Shiyan, Hubei, Chine, 430060
- Shiyan Taihe Hospital
-
Contact:
- Huaqiang Xie, MD
- Numéro de téléphone: +86 15971876767
- E-mail: xiehqiang@126.com
-
Wuhan, Hubei, Chine, 430060
- Renmin Hospital of Wuhan University
-
Contact:
- Songyun Wang, MD
- Numéro de téléphone: +86 13871262107
- E-mail: wsy7982@126.com
-
Wuhan, Hubei, Chine, 430060
- Wuhan Central Hospital
-
Contact:
- Long Wang, MD
- Numéro de téléphone: +86 15827552859
- E-mail: 319921605@qq.com
-
Wuhan, Hubei, Chine, 430060
- Wuhan Third Hospital
-
Contact:
- Dongsheng Li, MD
- Numéro de téléphone: +86 13100680307
- E-mail: lidongsheng693@sina.com
-
Xiangyang, Hubei, Chine, 430060
- Xiangyang Central Hospital
-
Contact:
- Xiaolin WU, MD
- Numéro de téléphone: +86 15571179695
- E-mail: 93316363@qq.com
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
Autres noms:
|
|
Comparateur 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.
|
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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of ventricular arrhythmias
Délai: 72 hours after PCI
|
Measurement: Count of ventricular arrhythmia episodes.
Measurement device: Wearable Holter monitors.
|
72 hours after PCI
|
|
Duration of ventricular arrhythmias
Délai: 72 hours after PCI
|
Measurement: Duration of ventricular arrhythmia episodes.
Measurement device: Wearable Holter monitors.
|
72 hours after PCI
|
|
NT-proBNP
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
IL-1β level
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 7 days after PCI
|
Echocardiographic measurement of left ventricular systolic function; Unit: % Measurement device: Echocardiographic.
|
7 days after PCI
|
|
Alanine aminotransferase (ALT) level
Délai: 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
Délai: Baseline (before stimulation) and 30 minutes after stimulation
|
Baseline (before stimulation) and 30 minutes after stimulation
|
|
|
Serum creatinine level
Délai: Baseline and 7 days after PCI
|
Serum creatinine concentration; Unit: μmol/L
|
Baseline and 7 days after PCI
|
|
IL-6 level
Délai: 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
Délai: 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
Délai: Baseline and 1, 3, 7 days after PCI
|
Serum neuropeptide Y concentration; Unit: pg/mL
|
Baseline and 1, 3, 7 days after PCI
|
|
SDANN
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 72 hours after PCI
|
Low frequency power of heart rate variability; Unit: ms² Measurement device: Wearable Holter monitors.
|
72 hours after PCI
|
|
HF power
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: Baseline and 7 days after PCI
|
Serum aspartate aminotransferase activity; Unit: U/L
|
Baseline and 7 days after PCI
|
|
Blood urea nitrogen (BUN) level
Délai: Baseline and 7 days after PCI
|
Blood urea nitrogen concentration; Unit: mmol/L
|
Baseline and 7 days after PCI
|
|
Estimated glomerular filtration rate (eGFR)
Délai: Baseline and 7 days after PCI
|
Estimated glomerular filtration rate calculated using serum creatinine; Unit: mL/min
|
Baseline and 7 days after PCI
|
|
TP
Délai: 72 hours after PCI
|
Total power of heart rate variability; Unit: ms² Measurement device: Wearable Holter monitors.
|
72 hours after PCI
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
5 mai 2026
Achèvement primaire (Estimé)
1 avril 2027
Achèvement de l'étude (Estimé)
1 avril 2027
Dates d'inscription aux études
Première soumission
28 avril 2026
Première soumission répondant aux critères de contrôle qualité
12 mai 2026
Première publication (Réel)
14 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
14 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 mai 2026
Dernière vérification
1 avril 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- WDRY2026-K086
- 82570593 (Autre subvention/numéro de financement: National Natural Science Foundation of China (NSFC))
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
INDÉCIS
Description du régime IPD
IPD sharing is currently undecided due to ongoing evaluation of participant privacy safeguards, data security requirements, and multicenter regulatory frameworks.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .