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NCT Number: NCT07058857

The Effect of Low-Level Tragus Stimulation on Echocardiographic Parameters in Patients With ST-Segment Elevation Myocardial Infarction - A Single-Centre Randomized Control Trial

The goal of this clinical trial is to learn the effect of low level tragus stimulation (LLTS) on echocardiographic parameter in patient with ST-segment Elevation Myocardial Infarction (STEMI) who undergo primart percutaneous coronary intervention (PPCI). 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 left ventricular ejection fraction in patients with STEMI? Does LLTS could alter wall motion score index in patients with STEMI? Does LLTS could alter diastolic dysfunction 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..

Both groups undergo transthoracal echocardiographi examination before and after PPCI..

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Key information

Conditions

ST Elevation Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–75 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. Left Ventricular Ejection Fraction

    Time frame: Before PPCI, 1 day after PPCI, and 30 days after PPCI

    Left Ventricular Ejection Fraction measured by transthoracic echocardiography

Secondary outcomes

  1. Wall Motion Score Index

    Time frame: Before PPCI, 1 day after PPCI, and 30 days after PPCI

    Wall Motion Score Index measured by transthoracic echocardiography

  2. Diastolic Function

    Time frame: Before PPCI, 1 day after PPCI, and 30 days after PPCI

    Diastolic Function measured by transthoracic echocardiography

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

Acronym: ELITE-STEMI

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 10, 2025
Registry last updated
Jul 10, 2025

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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