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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)

2026年5月12日 更新者：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

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

介入

入学 (推定)

100

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Songyun Wang, MD
  • 電話番号：+86 13871262107
  • メール：wsy7982@126.com

研究場所

  • 中国
    • Hubei
      • Huangshi、Hubei、中国、430060
        • Huangshi Central Hospital
        • コンタクト：
      • Jingzhou、Hubei、中国、430060
        • Jingzhou Central Hospital
        • コンタクト：
          • Keping Yang, MD
          • 電話番号：+86 18107168679
          • メール：30461400@qq.com
      • Shiyan、Hubei、中国、430060
        • Shiyan Taihe Hospital
        • コンタクト：
      • Wuhan、Hubei、中国、430060
        • Renmin Hospital of Wuhan University
        • コンタクト：
          • Songyun Wang, MD
          • 電話番号：+86 13871262107
          • メール：wsy7982@126.com
      • Wuhan、Hubei、中国、430060
        • Wuhan Central Hospital
        • コンタクト：
      • Wuhan、Hubei、中国、430060
        • Wuhan Third Hospital
        • コンタクト：
      • Xiangyang、Hubei、中国、430060
        • Xiangyang Central Hospital
        • コンタクト：
          • Xiaolin WU, MD
          • 電話番号：+86 15571179695
          • メール：93316363@qq.com

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
デバイス：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.
他の名前：
  • 利府
  • Ultrasound stellate ganglion modulation
プラセボコンパレーター：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.
デバイス：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.
他の名前：
  • シャム・リフ
  • Sham ultrasound neuromodulation

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Number of ventricular arrhythmias
時間枠：72 hours after PCI
Measurement: Count of ventricular arrhythmia episodes. Measurement device: Wearable Holter monitors.
72 hours after PCI
Duration of ventricular arrhythmias
時間枠：72 hours after PCI
Measurement: Duration of ventricular arrhythmia episodes. Measurement device: Wearable Holter monitors.
72 hours after PCI
NT-proBNP
時間枠：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

二次結果の測定

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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Renmin Hospital of Wuhan University

協力者

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

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年5月5日

一次修了 (推定)

2027年4月1日

研究の完了 (推定)

2027年4月1日

試験登録日

最初に提出

2026年4月28日

QC基準を満たした最初の提出物

2026年5月12日

最初の投稿 (実際)

2026年5月14日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月14日

QC基準を満たした最後の更新が送信されました

2026年5月12日

最終確認日

2026年4月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • WDRY2026-K086
  • 82570593 (その他の助成金/資金番号：National Natural Science Foundation of China (NSFC))

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

IPD プランの説明

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

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いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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