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NCT Number: 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)

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)

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Kariadi Central General Hospital

Semarang, Central of Java, Indonesia

Location status: Recruiting

Location contact

Leo Deddy Pradipta

CONTACT

[email protected]

+6281316499074

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Parasym Neuromodulation Device (Treatment Group)

Device

Participant will undergo stimulation in their left tragus for 60 minutes by using Parasym device

Parasym Neuromodulation Device (Sham Group)

Device

Participant will undergo implantation of Parasym device lead in their left tragus but without any stimulation for 60 minutes

Primary outcomes

  1. 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

  1. Heart Rate Variability

    Time frame: Before and After LLTS and Primary PCI (approximately within 24 to 48 hours after PPCI)

    Heart Rate Variability measurement by using WeCardio device

  2. Neutrophil-Lymphocyte Ratio

    Time frame: Before and After LLTS and Primary PCI (approximately within 24 to 48 hours after PPCI)

    Neutrophil-Lymphocyte Ratio from laboratory findings

Study contacts

Contact information is provided by the study sponsor or research team.

Leo Deddy Pradipta

CONTACT

[email protected]

+6281316499074

Sponsors and collaborators

Lead sponsor

Universitas Diponegoro

Other

Registry information

Official study 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

Acronym: TESLA-STEMI

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 5, 2024
Registry last updated
Aug 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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