NCT07058857

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Universitas Diponegoro · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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..

Conditions

• ST Elevation Myocardial Infarction

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-09-01
• Completion: 2025-09-30
• First posted: 2025-07-10
• Last updated: 2025-07-10

Locations

1 site across 1 country: Indonesia