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. května 2026 aktualizováno: 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
Přehled studie
Postavení
Zatím nenabíráme
Typ studie
Intervenční
Zápis (Odhadovaný)
100
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Songyun Wang, MD
- Telefonní číslo: +86 13871262107
- E-mail: wsy7982@126.com
Studijní místa
-
-
Hubei
-
Huangshi, Hubei, Čína, 430060
- Huangshi Central Hospital
-
Kontakt:
- Daoqun Jin, MD
- Telefonní číslo: +86 13597680361
- E-mail: edongheart@163.com
-
Jingzhou, Hubei, Čína, 430060
- Jingzhou Central Hospital
-
Kontakt:
- Keping Yang, MD
- Telefonní číslo: +86 18107168679
- E-mail: 30461400@qq.com
-
Shiyan, Hubei, Čína, 430060
- Shiyan Taihe Hospital
-
Kontakt:
- Huaqiang Xie, MD
- Telefonní číslo: +86 15971876767
- E-mail: xiehqiang@126.com
-
Wuhan, Hubei, Čína, 430060
- Renmin Hospital of Wuhan University
-
Kontakt:
- Songyun Wang, MD
- Telefonní číslo: +86 13871262107
- E-mail: wsy7982@126.com
-
Wuhan, Hubei, Čína, 430060
- Wuhan Central Hospital
-
Kontakt:
- Long Wang, MD
- Telefonní číslo: +86 15827552859
- E-mail: 319921605@qq.com
-
Wuhan, Hubei, Čína, 430060
- Wuhan Third Hospital
-
Kontakt:
- Dongsheng Li, MD
- Telefonní číslo: +86 13100680307
- E-mail: lidongsheng693@sina.com
-
Xiangyang, Hubei, Čína, 430060
- Xiangyang Central Hospital
-
Kontakt:
- Xiaolin WU, MD
- Telefonní číslo: +86 15571179695
- E-mail: 93316363@qq.com
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
Ostatní jména:
|
|
Komparátor placeba: 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.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of ventricular arrhythmias
Časové okno: 72 hours after PCI
|
Measurement: Count of ventricular arrhythmia episodes.
Measurement device: Wearable Holter monitors.
|
72 hours after PCI
|
|
Duration of ventricular arrhythmias
Časové okno: 72 hours after PCI
|
Measurement: Duration of ventricular arrhythmia episodes.
Measurement device: Wearable Holter monitors.
|
72 hours after PCI
|
|
NT-proBNP
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
IL-1β level
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 7 days after PCI
|
Echocardiographic measurement of left ventricular systolic function; Unit: % Measurement device: Echocardiographic.
|
7 days after PCI
|
|
Alanine aminotransferase (ALT) level
Časové okno: 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
Časové okno: Baseline (before stimulation) and 30 minutes after stimulation
|
Baseline (before stimulation) and 30 minutes after stimulation
|
|
|
Serum creatinine level
Časové okno: Baseline and 7 days after PCI
|
Serum creatinine concentration; Unit: μmol/L
|
Baseline and 7 days after PCI
|
|
IL-6 level
Časové okno: 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
Časové okno: 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
Časové okno: Baseline and 1, 3, 7 days after PCI
|
Serum neuropeptide Y concentration; Unit: pg/mL
|
Baseline and 1, 3, 7 days after PCI
|
|
SDANN
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 72 hours after PCI
|
Low frequency power of heart rate variability; Unit: ms² Measurement device: Wearable Holter monitors.
|
72 hours after PCI
|
|
HF power
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: Baseline and 7 days after PCI
|
Serum aspartate aminotransferase activity; Unit: U/L
|
Baseline and 7 days after PCI
|
|
Blood urea nitrogen (BUN) level
Časové okno: Baseline and 7 days after PCI
|
Blood urea nitrogen concentration; Unit: mmol/L
|
Baseline and 7 days after PCI
|
|
Estimated glomerular filtration rate (eGFR)
Časové okno: Baseline and 7 days after PCI
|
Estimated glomerular filtration rate calculated using serum creatinine; Unit: mL/min
|
Baseline and 7 days after PCI
|
|
TP
Časové okno: 72 hours after PCI
|
Total power of heart rate variability; Unit: ms² Measurement device: Wearable Holter monitors.
|
72 hours after PCI
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
5. května 2026
Primární dokončení (Odhadovaný)
1. dubna 2027
Dokončení studie (Odhadovaný)
1. dubna 2027
Termíny zápisu do studia
První předloženo
28. dubna 2026
První předloženo, které splnilo kritéria kontroly kvality
12. května 2026
První zveřejněno (Aktuální)
14. května 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
14. května 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
12. května 2026
Naposledy ověřeno
1. dubna 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- WDRY2026-K086
- 82570593 (Jiné číslo grantu/financování: National Natural Science Foundation of China (NSFC))
Plán pro data jednotlivých účastníků (IPD)
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Popis plánu IPD
IPD sharing is currently undecided due to ongoing evaluation of participant privacy safeguards, data security requirements, and multicenter regulatory frameworks.
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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