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)

Not Applicable

Recruiting

• Conditions: ST Elevation Myocardial Infarction
• Interventions: Device: Parasym Neuromodulation Device (Treatment Group); Device: Parasym Neuromodulation Device (Sham Group)

• Registration Number: NCT06537583
• Lead Sponsor: Universitas Diponegoro

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-24
• Study First Submitted QC: 2024-07-31
• Last Update Submitted: 2024-07-31
• Study First Posted: 2024-08-05
• Last Update Posted: 2024-08-05
• Primary Completion: 2024-08-31
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Level Tragus Stimulation Group	Parasym Neuromodulation Device (Sham Group)	Participant will undergo low level tragus stimulation using Parasym Device
Sham Control Group	Parasym Neuromodulation Device (Treatment Group)	Participant will have Parasym Device implanted in their tragus without any active stimulation from the device
Sham Control Group	Parasym Neuromodulation Device (Sham Group)	Participant will have Parasym Device implanted in their tragus without any active stimulation from the device
Low Level Tragus Stimulation Group	Parasym Neuromodulation Device (Treatment Group)	Participant will undergo low level tragus stimulation using Parasym Device

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiovascular Events	During hospitalization around up to 1 weeks	Consist of mortality, reinfarction, stroke, lethal arrhtyhmia, acute lung oedema, cardiogenic shock

Secondary Outcome Measures

Name	Time	Method
Neutrophil-Lymphocyte Ratio	Before and After LLTS and Primary PCI (approximately within 24 to 48 hours after PPCI)	Neutrophil-Lymphocyte Ratio from laboratory findings
Heart Rate Variability	Before and After LLTS and Primary PCI (approximately within 24 to 48 hours after PPCI)	Heart Rate Variability measurement by using WeCardio device

Trial Locations

Locations (1)

Dr. Kariadi Central General Hospital; 🇮🇩 Semarang, Central Of Java, Indonesia