Actively Recruiting
Studying Low-Level Tragus Stimulation to Improve Heart Function After a Heart Attack in Adults Aged 18 to 75
Led by Universitas Diponegoro · Updated on 2025-07-10
100
Participants Needed
1
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of low-level tragus stimulation LLTS on heart function in patients who have experienced ST-segment Elevation Myocardial Infarction STEMI and are undergoing primary percutaneous coronary intervention PPCI. This study aims to understand if LLTS can improve measures such as left ventricular ejection fraction, wall motion score index, and diastolic function compared to a sham control. The safety of LLTS in this setting is also being assessed. Participants will be randomly assigned to one of two groups the treatment group receiving LLTS via the Parasym device on the left tragus for 60 minutes, or the sham control group where the Parasym device is implanted without active stimulation for the same duration. Both groups will undergo transthoracic echocardiography examinations before and after PPCI to assess heart function. During the study, participants will have echocardiographic measurements taken before PPCI, one day after PPCI, and 30 days after PPCI to monitor changes in left ventricular ejection fraction, wall motion score index, and diastolic function. The study will last through these time points to evaluate both the effect and safety of LLTS treatment in STEMI patients.
CONDITIONS
Brief Title
The Effect of Low-Level Tragus Stimulation on Echocardiographic Parameters in Patients With ST-Segment Elevation Myocardial Infarction - A Single-Centre Randomized Control Trial
Research Team
L
Leo Deddy Pradipta
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