Actively Recruiting
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)
Led by Universitas Diponegoro · Updated on 2024-08-05
100
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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)
CONDITIONS
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 (TESLA-STEMI)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- STEMI onset less than 12 hours
- Participant agrees to be included in this study
- Killip class I or II at presentation
- Systolic blood pressure greater than 90 mmHg or mean arterial pressure greater than 65 mmHg
- Sinus rhythm present
You will not qualify if you...
- History of myocardial infarction, stroke, heart failure with reduced ejection fraction, chronic total occlusion on prior coronary angiography, chronic kidney disease with eGFR less than 30 or on hemodialysis, malignancy, hematology disease, autoimmune or other chronic diseases
- Presence of permanent pacemaker
- Acute infection
- Pregnancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Dr. Kariadi Central General Hospital
Semarang, Central of Java, Indonesia
Actively Recruiting
Research Team
L
Leo Deddy Pradipta
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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