NCT06537583

The Efficacy and Safety of Low-Level Tragus Stimulation on Heart Rate Variability, Neutrophil-Lymphocyte Ratio, and Major Adverse Cardiovascular Events in Patients With ST-Segment Elevation Myocardial Infarction (TESLA-STEMI)

The Efficacy and Safety of Low-Level Tragus Stimulation on Heart Rate Variability, Neutrophil-Lymphocyte Ratio, and Major Adverse Cardiovascular Events in Patients With ST-Segment Elevation Myocardial Infarction

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Universitas Diponegoro · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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)

Conditions

• ST Elevation Myocardial Infarction

Interventions

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

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-08-31
• Completion: 2024-09-30
• First posted: 2024-08-05
• Last updated: 2024-08-05

Locations

1 site across 1 country: Indonesia