The goal of this clinical trial is to learn the effect of low level tragus stimulation (LLTS) on heart rate variability (HRV), neutrophil-lymphocyte ratio, and major adverse cardiovascular events in patient with ST-segment Elevation Myocardial Infarction (STEMI). It will also learn about the safety of LLTS in such setting. The main questions, it aims to answer are compared with sham control:
1. Does LLTS could alter low frequency/high frequency ratio in patients with STEMI? 2. Does LLTS could alter neutrophil-lymphocyte ratio in patients with STEMI? 3. Does LLTS could decrease mortality in patients with STEMI? 4. Does LLTS could decrease reinfarction event in patients with STEMI? 5. Does LLTS could decrease stroke event in patients with STEMI? 6. Does LLTS could decrease lethal arrhythmia event in patients with STEMI? 7. Does LLTS could decrease acute lung oedema event in patients with STEMI? 8. Does LLTS could decrease cardiogenic shock event 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, then both of them:
1. Undergo laboratory examination before Primary Percutaneous Coronary Intervention (PPCI) 2. Undergo HRV measurement using WeCardio device before Primary Percutaneous Coronary Intervention (PPCI) 3. Undergo LLTS (treatment group will have stimulation) for 60 minutes, however, sham control will not have stimulation, before PPCI 4. Undergo PPCI 5. Undergo laboratory examination after Primary Percutaneous Coronary Intervention (PPCI) 6. Undergo HRV measurement using WeCardio device after Primary Percutaneous Coronary Intervention (PPCI)
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
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
Parallel
Parasym Neuromodulation Device (Treatment Group)
DeviceParticipant will undergo stimulation in their left tragus for 60 minutes by using Parasym device
Parasym Neuromodulation Device (Sham Group)
DeviceParticipant will undergo implantation of Parasym device lead in their left tragus but without any stimulation for 60 minutes
Major Adverse Cardiovascular Events
Consist of mortality, reinfarction, stroke, lethal arrhtyhmia, acute lung oedema, cardiogenic shock
Heart Rate Variability
Heart Rate Variability measurement by using WeCardio device
Neutrophil-Lymphocyte Ratio
Neutrophil-Lymphocyte Ratio from laboratory findings
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