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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Parasym Neuromodulation Device (Treatment Group)
DeviceParticipant will undergo stimulation in their left tragus for 60 minutes by using Parasym device
Parasym Neuromodulation Device (Sham Group)
DeviceParticipant will undergo implantation of Parasym device lead in their left tragus but without any stimulation for 60 minutes
Treatment groups
Trial outcomes
Primary outcomes
Left Ventricular Ejection Fraction
Left Ventricular Ejection Fraction measured by transthoracic echocardiography
Secondary outcomes
Wall Motion Score Index
Wall Motion Score Index measured by transthoracic echocardiography
Diastolic Function
Diastolic Function measured by transthoracic echocardiography
Sponsors and contacts
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