The Effect of Low-Level Tragus Stimulation on Echocardiographic Parameters in Patients With ST-Segment Elevation Myocardial Infarction - A Single-Centre Randomized Control Trial

Обзор

The goal of this clinical trial is to learn the effect of low level tragus stimulation (LLTS) on echocardiographic parameter in patient with ST-segment Elevation Myocardial Infarction (STEMI) who undergo primart percutaneous coronary intervention (PPCI). It will also learn about the safety of LLTS in such setting. The main questions, it aims to answer are compared with sham control: Does LLTS could alter left ventricular ejection fraction in patients with STEMI? Does LLTS could alter wall motion score index in patients with STEMI? Does LLTS could alter diastolic dysfunction in patients with STEMI? Researchers will compare LLTS to sham LLTS control to see if LLTS have benefit in participants with STEMI participants will divided into two group i.e. treatment group vs control (sham/placebo) group.. Both groups undergo transthoracal echocardiographi examination before and after PPCI..

Вмешательства

• Устройство Parasym Neuromodulation Device (Treatment Group)
  Participant will undergo stimulation in their left tragus for 60 minutes by using Parasym device
• Устройство Parasym Neuromodulation Device (Sham Group)
  Participant will undergo implantation of Parasym device lead in their left tragus but without any stimulation for 60 minutes

Первичные конечные точки

• Left Ventricular Ejection Fraction [Срок оценки: Before PPCI, 1 day after PPCI, and 30 days after PPCI]

Вторичные конечные точки (2)

• Wall Motion Score Index [Срок оценки: Before PPCI, 1 day after PPCI, and 30 days after PPCI]
• Diastolic Function [Срок оценки: Before PPCI, 1 day after PPCI, and 30 days after PPCI]

Критерии участия

Критерии включения

• Onset STEMI less than 12 hours
• Participant agreed to be included in this study
• Killip class I - II on presentation
• SBP >90 mmHg and/or MAP >65 mmHg
• Sinus rhtyhm

Критерии исключения

• History of myocardial infarction, stroke, heart failure with reduce ejection fraction, chronic total occlussion on prior coronary angiography, chronic kidney disease (eGFR < 30) or on hemodyalisis, malignancy, hematology disease, autoimmune, or other chronic diseases
• On permanent pacemaker
• Acute infection
• Pregnant woman

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Индонезия · 1 центр

• Dr. Kariadi Central General Hospital — Semarang

Публикации

• Yu L, Huang B, Po SS, Tan T, Wang M, Zhou L, Meng G, Yuan S, Zhou X, Li X, Wang Z, Wang S, Jiang H. Low-Level Tragus Stimulation for the Treatment of Ischemia and Reperfusion Injury in Patients With ST-Segment Elevation Myocardial Infarction: A Proof-of-Concept Study. JACC Cardiovasc Interv. 2017 Aug 14;10(15):1511-1520. doi: 10.1016/j.jcin.2017.04.036. PMID 28797427
• Redgrave J, Day D, Leung H, Laud PJ, Ali A, Lindert R, Majid A. Safety and tolerability of Transcutaneous Vagus Nerve stimulation in humans; a systematic review. Brain Stimul. 2018 Nov-Dec;11(6):1225-1238. doi: 10.1016/j.brs.2018.08.010. Epub 2018 Aug 23. PMID 30217648

Идентификаторы

NCT: NCT07058857 · Undip_Kardio 5

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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