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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Universitas Diponegoro
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Major Adverse Cardiovascular Events
Study Overview
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:
- Does LLTS could alter low frequency/high frequency ratio in patients with STEMI?
- Does LLTS could alter neutrophil-lymphocyte ratio in patients with STEMI?
- Does LLTS could decrease mortality in patients with STEMI?
- Does LLTS could decrease reinfarction event in patients with STEMI?
- Does LLTS could decrease stroke event in patients with STEMI?
- Does LLTS could decrease lethal arrhythmia event in patients with STEMI?
- Does LLTS could decrease acute lung oedema event in patients with STEMI?
- 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:
- Undergo laboratory examination before Primary Percutaneous Coronary Intervention (PPCI)
- Undergo HRV measurement using WeCardio device before Primary Percutaneous Coronary Intervention (PPCI)
- Undergo LLTS (treatment group will have stimulation) for 60 minutes, however, sham control will not have stimulation, before PPCI
- Undergo PPCI
- Undergo laboratory examination after Primary Percutaneous Coronary Intervention (PPCI)
- Undergo HRV measurement using WeCardio device after Primary Percutaneous Coronary Intervention (PPCI)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Participant will not know either they include in treatment or control group
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Low Level Tragus Stimulation Group
Participant will undergo low level tragus stimulation using Parasym Device
Intervention: Parasym Neuromodulation Device (Treatment Group) (Device)
Low Level Tragus Stimulation Group
Participant will undergo low level tragus stimulation using Parasym Device
Intervention: Parasym Neuromodulation Device (Sham Group) (Device)
Sham Control Group
Participant will have Parasym Device implanted in their tragus without any active stimulation from the device
Intervention: Parasym Neuromodulation Device (Treatment Group) (Device)
Sham Control Group
Participant will have Parasym Device implanted in their tragus without any active stimulation from the device
Intervention: Parasym Neuromodulation Device (Sham Group) (Device)
Outcomes
Primary Outcomes
Major Adverse Cardiovascular Events
Time Frame: During hospitalization around up to 1 weeks
Consist of mortality, reinfarction, stroke, lethal arrhtyhmia, acute lung oedema, cardiogenic shock
Secondary Outcomes
- Neutrophil-Lymphocyte Ratio(Before and After LLTS and Primary PCI (approximately within 24 to 48 hours after PPCI))
- Heart Rate Variability(Before and After LLTS and Primary PCI (approximately within 24 to 48 hours after PPCI))
Investigators
Sodiqur Rifqi
Principal Investigator; Former of Head of Department of Cardiovascular Medicine Faculty of Medicine Universitas Diponegoro
Universitas Diponegoro