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)

Universitas Diponegoro

Status: Enrolling

Conditions: ST Elevation Myocardial Infarction

Treatments: Device: Parasym Neuromodulation Device (Treatment Group); Device: Parasym Neuromodulation Device (Sham Group)

Study type: Interventional

Funder types: Other

Identifiers

NCT06537583

Undip

Details and patient eligibility

About

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)

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Low Level Tragus Stimulation Group

Experimental group

Description:

Participant will undergo low level tragus stimulation using Parasym Device

Treatment:

Device: Parasym Neuromodulation Device (Sham Group)

Device: Parasym Neuromodulation Device (Treatment Group)

Sham Control Group

Sham Comparator group

Description:

Participant will have Parasym Device implanted in their tragus without any active stimulation from the device

Treatment:

Device: Parasym Neuromodulation Device (Sham Group)

Device: Parasym Neuromodulation Device (Treatment Group)