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Acute ST-segment Elevation Myocardial Infarction (Patients Undergoing Emergency PCI)US-PRAYNCT07587294

Efficacy and Safety of Ultrasound Modulation of Stellate Ganglion for the Prevention of Ventricular Arrhythmia in Patients With ST-segment Elevation Myocardial Infarction

A study testing Ultrasound modulation of the left stellate ganglion in people with Acute ST-segment Elevation Myocardial Infarction (Patients Undergoing Emergency PCI), run by Renmin Hospital of Wuhan University at 7 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Ultrasound modulation of the left stellate ganglion
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
7 sitesChina
Study dates
15 May 2026to 1 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 15Show fewer
  • 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.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Songyun Wang, MD contact

+86 13871262107

wsy7982@126.com

7 sites in 1 country

China7 sites, 7 recruiting
  • Huangshi Central Hospital

    Huangshi, Hubei, 430060

    Daoqun Jin, MD, +86 13597680361, edongheart@163.com

    Not yet recruiting
  • Jingzhou Central Hospital

    Jingzhou, Hubei, 430060

    Keping Yang, MD, +86 18107168679, 30461400@qq.com

    Not yet recruiting
  • Shiyan Taihe Hospital

    Shiyan, Hubei, 430060

    Huaqiang Xie, MD, +86 15971876767, xiehqiang@126.com

    Not yet recruiting
  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

    Songyun Wang, MD, +86 13871262107, wsy7982@126.com

    Recruiting
  • Wuhan Central Hospital

    Wuhan, Hubei, 430060

    Long Wang, MD, +86 15827552859, 319921605@qq.com

    Not yet recruiting
  • Wuhan Third Hospital

    Wuhan, Hubei, 430060

    Dongsheng Li, MD, +86 13100680307, lidongsheng693@sina.com

    Not yet recruiting
  • Xiangyang Central Hospital

    Xiangyang, Hubei, 430060

    Xiaolin WU, MD, +86 15571179695, 93316363@qq.com

    Not yet recruiting

Other trials in China

About this study

Official title: 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:

Read more
  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
Being tested
Ultrasound modulation of the left stellate ganglion, Sham ultrasound modulation of the left stellate ganglion
Keywords
Ultrasound, Stellate ganglion, Neuromodulation, STEMI, Ventricular arrhythmia
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound modulation of the left stellate ganglionDevice

    Also called Ultrasound stellate ganglion modulation, LIFU

    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.

  • Sham ultrasound modulation of the left stellate ganglionDevice

    Also called Sham ultrasound neuromodulation, Sham LIFU

    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.

Study groups in NCT07587294
Study groupRoleWhat they receive
Ultrasound stimulation groupExperimentalSubjects 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.
Receives: Device: Ultrasound modulation of the left stellate ganglion
Sham groupPlacebo comparatorSubjects 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.
Receives: Device: Sham ultrasound modulation of the left stellate ganglion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of ventricular arrhythmias

    Measurement: Count of ventricular arrhythmia episodes. Measurement device: Wearable Holter monitors.

    Measured: 72 hours after PCI

  2. Duration of ventricular arrhythmias

    Measurement: Duration of ventricular arrhythmia episodes. Measurement device: Wearable Holter monitors.

    Measured: 72 hours after PCI

  3. NT-proBNP

    Serum N-terminal pro-brain natriuretic peptide concentration; Unit: pg/mL

    Measured: Baseline and 1, 3, 7 days after PCI

Secondary outcomes (26)
  1. IL-1β level

    Serum IL-1β concentration; Unit: pg/mL

    Measured: Baseline and 1, 3, 7 days after PCI

  2. Norepinephrine level

    Serum norepinephrine concentration; Unit: pg/mL

    Measured: Baseline and 1, 3, 7 days after PCI

  3. Cardiac troponin T (cTnT) level

    Serum cardiac troponin T concentration; Unit: ng/L

    Measured: Baseline and 1, 3, 7 days after PCI

  4. SDNN

    Standard deviation of normal-to-normal intervals; Unit: ms Measurement device: Wearable Holter monitors

    Measured: 72 hours after PCI

  5. Left ventricular ejection fraction (LVEF)

    Echocardiographic measurement of left ventricular systolic function; Unit: % Measurement device: Echocardiographic.

    Measured: 7 days after PCI

  6. Alanine aminotransferase (ALT) level

    Serum alanine aminotransferase activity; Unit: U/L

    Measured: Baseline and 7 days after PCI

  7. Local skin temperature before and after stimulation

    Measured: Baseline (before stimulation) and 30 minutes after stimulation

  8. Serum creatinine level

    Serum creatinine concentration; Unit: μmol/L

    Measured: Baseline and 7 days after PCI

  9. IL-6 level

    Serum IL-6 concentration; Unit: pg/mL

    Measured: Baseline and 1, 3, 7 days after PCI

  10. TNF-α level

    Serum TNF-α concentration; Unit: pg/mL

    Measured: Baseline and 1, 3, 7 days after PCI

  11. Neuropeptide Y level

    Serum neuropeptide Y concentration; Unit: pg/mL

    Measured: Baseline and 1, 3, 7 days after PCI

  12. SDANN

    Standard deviation of the averages of normal-to-normal intervals in all 5-minute segments; Unit: ms Measurement device: Wearable Holter monitors

    Measured: 72 hours after PCI

  13. Creatine kinase-MB (CK-MB) level

    Serum creatine kinase-MB activity; Unit: U/L

    Measured: Baseline and 1, 3, 7 days after PCI

  14. SDANN

    Standard deviation of the averages of NN intervals in all 5-minute segments; Unit: ms Measurement device: Wearable Holter monitors.

    Measured: 72 hours after PCI

  15. SDNN Index

    Mean of the standard deviations of all NN intervals for all 5-minute segments ;Unit: ms Measurement device: Wearable Holter monitors.

    Measured: 72 hours after PCI

  16. RMSSD

    Root mean square of successive differences between normal heartbeats

    ; Unit: ms Measurement device: Wearable Holter monitors.

    Measured: 72 hours after PCI

  17. pNN50

    Percentage of successive NN intervals that differ by more than 50 ms

    ; Unit: % Measurement device: Wearable Holter monitors.

    Measured: 72 hours after PCI

  18. LF power

    Low frequency power of heart rate variability; Unit: ms² Measurement device: Wearable Holter monitors.

    Measured: 72 hours after PCI

  19. HF power

    High frequency power of heart rate variability; Unit: ms² Measurement device: Wearable Holter monitors.

    Measured: 72 hours after PCI

  20. LF/HF ratio

    Ratio of low frequency to high frequency power; Unit: ratio Measurement device: Wearable Holter monitors.

    Measured: 72 hours after PCI

  21. Left ventricular end-systolic volume (LVESV)

    Echocardiographic measurement of left ventricular volume at end-systole; Unit: mL Measurement device: Echocardiographic.

    Measured: 7 days after PCI

  22. Left ventricular end-systolic diameter (LVESD)

    Echocardiographic measurement of left ventricular diameter at end-systole; Unit: mm Measurement device: Echocardiographic.

    Measured: 7 days after PCI

  23. Aspartate aminotransferase (AST) level

    Serum aspartate aminotransferase activity; Unit: U/L

    Measured: Baseline and 7 days after PCI

  24. Blood urea nitrogen (BUN) level

    Blood urea nitrogen concentration; Unit: mmol/L

    Measured: Baseline and 7 days after PCI

  25. Estimated glomerular filtration rate (eGFR)

    Estimated glomerular filtration rate calculated using serum creatinine; Unit: mL/min

    Measured: Baseline and 7 days after PCI

  26. TP

    Total power of heart rate variability; Unit: ms² Measurement device: Wearable Holter monitors.

    Measured: 72 hours after PCI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2026
  2. Study start15 May 2026
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion1 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07587294
Sponsor's protocol ID
WDRY2026-K086
Other IDs
82570593
Acronym
US-PRAY
Status last verified
Apr 2026
First submitted
28 Apr 2026
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: IPD sharing is currently undecided due to ongoing evaluation of participant privacy safeguards, data security requirements, and multicenter regulatory frameworks.

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound modulation of the left stellate ganglion in people with Acute ST-segment Elevation Myocardial Infarction (Patients Undergoing Emergency PCI), run by Renmin Hospital of Wuhan University at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Songyun Wang, MD (+86 13871262107, wsy7982@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of ventricular arrhythmias (time frame: 72 hours after PCI). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.

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