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)
tiistai 12. toukokuuta 2026 päivittänyt: 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
Tutkimuksen yleiskatsaus
Tila
Ei vielä rekrytointia
Opintotyyppi
Interventio
Ilmoittautuminen (Arvioitu)
100
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: Songyun Wang, MD
- Puhelinnumero: +86 13871262107
- Sähköposti: wsy7982@126.com
Opiskelupaikat
-
-
Hubei
-
Huangshi, Hubei, Kiina, 430060
- Huangshi Central Hospital
-
Ottaa yhteyttä:
- Daoqun Jin, MD
- Puhelinnumero: +86 13597680361
- Sähköposti: edongheart@163.com
-
Jingzhou, Hubei, Kiina, 430060
- Jingzhou Central Hospital
-
Ottaa yhteyttä:
- Keping Yang, MD
- Puhelinnumero: +86 18107168679
- Sähköposti: 30461400@qq.com
-
Shiyan, Hubei, Kiina, 430060
- Shiyan Taihe Hospital
-
Ottaa yhteyttä:
- Huaqiang Xie, MD
- Puhelinnumero: +86 15971876767
- Sähköposti: xiehqiang@126.com
-
Wuhan, Hubei, Kiina, 430060
- Renmin Hospital of Wuhan University
-
Ottaa yhteyttä:
- Songyun Wang, MD
- Puhelinnumero: +86 13871262107
- Sähköposti: wsy7982@126.com
-
Wuhan, Hubei, Kiina, 430060
- Wuhan Central Hospital
-
Ottaa yhteyttä:
- Long Wang, MD
- Puhelinnumero: +86 15827552859
- Sähköposti: 319921605@qq.com
-
Wuhan, Hubei, Kiina, 430060
- Wuhan Third Hospital
-
Ottaa yhteyttä:
- Dongsheng Li, MD
- Puhelinnumero: +86 13100680307
- Sähköposti: lidongsheng693@sina.com
-
Xiangyang, Hubei, Kiina, 430060
- Xiangyang Central Hospital
-
Ottaa yhteyttä:
- Xiaolin WU, MD
- Puhelinnumero: +86 15571179695
- Sähköposti: 93316363@qq.com
-
-
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Ei
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Nelinkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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.
Muut nimet:
|
|
Placebo Comparator: 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.
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Number of ventricular arrhythmias
Aikaikkuna: 72 hours after PCI
|
Measurement: Count of ventricular arrhythmia episodes.
Measurement device: Wearable Holter monitors.
|
72 hours after PCI
|
|
Duration of ventricular arrhythmias
Aikaikkuna: 72 hours after PCI
|
Measurement: Duration of ventricular arrhythmia episodes.
Measurement device: Wearable Holter monitors.
|
72 hours after PCI
|
|
NT-proBNP
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
IL-1β level
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 7 days after PCI
|
Echocardiographic measurement of left ventricular systolic function; Unit: % Measurement device: Echocardiographic.
|
7 days after PCI
|
|
Alanine aminotransferase (ALT) level
Aikaikkuna: 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
Aikaikkuna: Baseline (before stimulation) and 30 minutes after stimulation
|
Baseline (before stimulation) and 30 minutes after stimulation
|
|
|
Serum creatinine level
Aikaikkuna: Baseline and 7 days after PCI
|
Serum creatinine concentration; Unit: μmol/L
|
Baseline and 7 days after PCI
|
|
IL-6 level
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Baseline and 1, 3, 7 days after PCI
|
Serum neuropeptide Y concentration; Unit: pg/mL
|
Baseline and 1, 3, 7 days after PCI
|
|
SDANN
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 72 hours after PCI
|
Low frequency power of heart rate variability; Unit: ms² Measurement device: Wearable Holter monitors.
|
72 hours after PCI
|
|
HF power
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: Baseline and 7 days after PCI
|
Serum aspartate aminotransferase activity; Unit: U/L
|
Baseline and 7 days after PCI
|
|
Blood urea nitrogen (BUN) level
Aikaikkuna: Baseline and 7 days after PCI
|
Blood urea nitrogen concentration; Unit: mmol/L
|
Baseline and 7 days after PCI
|
|
Estimated glomerular filtration rate (eGFR)
Aikaikkuna: Baseline and 7 days after PCI
|
Estimated glomerular filtration rate calculated using serum creatinine; Unit: mL/min
|
Baseline and 7 days after PCI
|
|
TP
Aikaikkuna: 72 hours after PCI
|
Total power of heart rate variability; Unit: ms² Measurement device: Wearable Holter monitors.
|
72 hours after PCI
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Opintojen ennätyspäivät
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Opintojen valmistuminen (Arvioitu)
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Ensimmäinen lähetetty
Tiistai 28. huhtikuuta 2026
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Tiistai 12. toukokuuta 2026
Ensimmäinen Lähetetty (Todellinen)
Torstai 14. toukokuuta 2026
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
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Viimeksi vahvistettu
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Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- WDRY2026-K086
- 82570593 (Muu apuraha/rahoitusnumero: National Natural Science Foundation of China (NSFC))
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