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

Not Applicable

Recruiting

• Conditions: ST Elevation Myocardial Infarction

• Registration Number: NCT07058857
• Lead Sponsor: Universitas Diponegoro

Brief Summary

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..

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-01
• Status Verified: 2025-06
• Study First Submitted: 2025-06-30
• Study First Submitted QC: 2025-06-30
• Last Update Submitted: 2025-06-30
• Study First Posted: 2025-07-10
• Last Update Posted: 2025-07-10
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Left Ventricular Ejection Fraction	Before PPCI, 1 day after PPCI, and 30 days after PPCI	Left Ventricular Ejection Fraction measured by transthoracic echocardiography

Secondary Outcome Measures

Name	Time	Method
Wall Motion Score Index	Before PPCI, 1 day after PPCI, and 30 days after PPCI	Wall Motion Score Index measured by transthoracic echocardiography
Diastolic Function	Before PPCI, 1 day after PPCI, and 30 days after PPCI	Diastolic Function measured by transthoracic echocardiography

Trial Locations

Locations (1)

Dr. Kariadi Central General Hospital; 🇮🇩 Semarang, Central Of Java, Indonesia