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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. Mai 2026 aktualisiert von: 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

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

100

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Songyun Wang, MD
  • Telefonnummer: +86 13871262107
  • E-Mail: wsy7982@126.com

Studienorte

  • China
    • Hubei
      • Huangshi, Hubei, China, 430060
        • Huangshi Central Hospital
        • Kontakt:
      • Jingzhou, Hubei, China, 430060
        • Jingzhou Central Hospital
        • Kontakt:
      • Shiyan, Hubei, China, 430060
        • Shiyan Taihe Hospital
        • Kontakt:
      • Wuhan, Hubei, China, 430060
        • Renmin Hospital of Wuhan University
        • Kontakt:
      • Wuhan, Hubei, China, 430060
        • Wuhan Central Hospital
        • Kontakt:
      • Wuhan, Hubei, China, 430060
      • Xiangyang, Hubei, China, 430060
        • Xiangyang Central Hospital
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Gerät: 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.
Andere Namen:
  • LIFU
  • Ultrasound stellate ganglion modulation
Placebo-Komparator: 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.
Gerät: 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.
Andere Namen:
  • Schein-LIFU
  • Sham ultrasound neuromodulation

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of ventricular arrhythmias
Zeitfenster: 72 hours after PCI
Measurement: Count of ventricular arrhythmia episodes. Measurement device: Wearable Holter monitors.
72 hours after PCI
Duration of ventricular arrhythmias
Zeitfenster: 72 hours after PCI
Measurement: Duration of ventricular arrhythmia episodes. Measurement device: Wearable Holter monitors.
72 hours after PCI
NT-proBNP
Zeitfenster: 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

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Renmin Hospital of Wuhan University

Mitarbeiter

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

5. Mai 2026

Primärer Abschluss (Geschätzt)

1. April 2027

Studienabschluss (Geschätzt)

1. April 2027

Studienanmeldedaten

Zuerst eingereicht

28. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

12. Mai 2026

Zuerst gepostet (Tatsächlich)

14. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

14. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

12. Mai 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • WDRY2026-K086
  • 82570593 (Andere Zuschuss-/Finanzierungsnummer: National Natural Science Foundation of China (NSFC))

Plan für individuelle Teilnehmerdaten (IPD)

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UNENTSCHIEDEN

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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