ST Elevation Myocardial Infarction
Conditions
Keywords
ST-segment elevation myocardial infarction, Low level tragus stimulation, Left ventricular ejection fraction, Wall motion score index
Brief 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..
Interventions
Participant will undergo stimulation in their left tragus for 60 minutes by using Parasym device
Participant will undergo implantation of Parasym device lead in their left tragus but without any stimulation for 60 minutes
Sponsors
Universitas Diponegoro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participant will not know either they include in treatment or control group
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left Ventricular Ejection Fraction | Before PPCI, 1 day after PPCI, and 30 days after PPCI | Left Ventricular Ejection Fraction measured by transthoracic echocardiography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wall Motion Score Index | Before PPCI, 1 day after PPCI, and 30 days after PPCI | Wall Motion Score Index measured by transthoracic echocardiography |
| Diastolic Function | Before PPCI, 1 day after PPCI, and 30 days after PPCI | Diastolic Function measured by transthoracic echocardiography |
Countries
Indonesia
Contacts
Primary ContactLeo Deddy Pradipta
Outcome results
None listed