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
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Indonesia
Dr. Kariadi Central General Hospital
RECRUITING
Semarang
Contact Information
Primary
Leo Deddy Pradipta
dancingdeagle@gmail.com
+6281316499074
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2024-09-30
Participants
Target number of participants: 100
Treatments
Experimental: Low Level Tragus Stimulation Group
Participant will undergo low level tragus stimulation using Parasym Device
Sham_comparator: Sham Control Group
Participant will have Parasym Device implanted in their tragus without any active stimulation from the device
Sponsors
Leads: Universitas Diponegoro

This content was sourced from clinicaltrials.gov