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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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..

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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

Locations (1)

Dr. Kariadi Central General Hospital
Semarang, Central of Java, Indonesia