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

RecruitingNAAges 18 Years - 75 YearsAllUniversitas Diponegoro
NCT07058857 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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..

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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What it tests

  • Parasym Neuromodulation Device (Treatment Group)
  • Parasym Neuromodulation Device (Sham Group)
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Where

1 site
Dr. Kariadi Central General Hospital
Semarang, Indonesia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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