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

Universitas Diponegoro

Status: Enrolling

Conditions: ST Elevation Myocardial Infarction

Treatments: Device: Parasym Neuromodulation Device (Sham Group); Device: Parasym Neuromodulation Device (Treatment Group)

Study type: Interventional

Funder types: Other

Identifiers

NCT07058857

Undip_Kardio 5

Details and patient eligibility

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..

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Low Level Tragus Stimulation Group

Experimental group

Description:

Participant will undergo low level tragus stimulation using Parasym Device

Treatment:

Device: Parasym Neuromodulation Device (Treatment Group)

Device: Parasym Neuromodulation Device (Sham Group)

Sham Control Group

Sham Comparator group

Description:

Participant will have Parasym Device implanted in their tragus without any active stimulation from the device

Treatment:

Device: Parasym Neuromodulation Device (Treatment Group)

Device: Parasym Neuromodulation Device (Sham Group)