Clinical trial 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)
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ST Elevation Myocardial Infarction
Keywords: ST segment elevation myocardial infarction
Low level tragus stimulation
Heart rate variability
Neutrophil-lymphocyte ratio
Major adverse cardiovascular events
Lead sponsor: Universitas Diponegoro
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)


Eligibility criteria: 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

Primary outcomes:
measure: Major Adverse Cardiovascular Events
timeFrame: During hospitalization around up to 1 weeks
Secondary outcomes:
measure: Heart Rate Variability
timeFrame: Before and After LLTS and Primary PCI (approximately within 24 to 48 hours after PPCI)
measure: Neutrophil-Lymphocyte Ratio
timeFrame: Before and After LLTS and Primary PCI (approximately within 24 to 48 hours after PPCI)
Other outcomes:
Locations:
city: Semarang
country: Indonesia
facility: Dr. Kariadi Central General Hospital
state: Central Of Java
Study officials:
References:
citation: 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.
citation: 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.