RecruitingNot ApplicableNCT07058857

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


Sponsor

Universitas Diponegoro

Enrollment

100 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

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..


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Parasym Neuromodulation Device (Sham Group) and Parasym Neuromodulation Device (Treatment Group) for people with st elevation myocardial infarction. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEParasym Neuromodulation Device (Treatment Group)

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

DEVICEParasym Neuromodulation Device (Sham Group)

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


Locations(1)

Dr. Kariadi Central General Hospital

Semarang, Central of Java, Indonesia

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NCT07058857


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