Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
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

Led by Universitas Diponegoro · Updated on 2025-07-10

100

Participants Needed

1

Research Sites

38 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 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..

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Onset of ST-segment Elevation Myocardial Infarction (STEMI) less than 12 hours
  • Participant agrees to join the study
  • Killip class I or II at presentation
  • Systolic blood pressure above 90 mmHg and/or mean arterial pressure above 65 mmHg
  • Sinus rhythm present
Not Eligible

You will not qualify if you...

  • History of myocardial infarction, stroke, heart failure with reduced ejection fraction, chronic total occlusion on previous coronary angiography, chronic kidney disease with eGFR less than 30 or on hemodialysis, malignancy, hematology disease, autoimmune or other chronic diseases
  • Permanent pacemaker
  • Acute infection
  • Pregnant woman

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Dr. Kariadi Central General Hospital

Semarang, Central of Java, Indonesia

Actively Recruiting

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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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