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

NCT07058857 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-07-10

No results posted yet for this study

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..

Conditions

  • ST Elevation Myocardial Infarction

Interventions

DEVICE

Parasym Neuromodulation Device (Treatment Group)

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

DEVICE

Parasym Neuromodulation Device (Sham Group)

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

Sponsors & Collaborators

  • Universitas Diponegoro

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2025-09-01
Completion
2025-09-30

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07058857 on ClinicalTrials.gov