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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversitas Diponegoro

About this 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..

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Low Level Tragus Stimulation GroupExperimental treatment 2 interventions
Group B: Sham Control GroupSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

Left Ventricular Ejection Fraction

Left Ventricular Ejection Fraction measured by transthoracic echocardiography

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

Secondary outcomes

1

Wall Motion Score Index

Wall Motion Score Index measured by transthoracic echocardiography

Time frame
Before PPCI, 1 day after PPCI, and 30 days after PPCI
2

Diastolic Function

Diastolic Function measured by transthoracic echocardiography

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

Other outcomes

Sponsors and contacts

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