Low-level tragus stimulation to improve heart function after ST-elevation heart attack
Official 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
Run by Universitas Diponegoro · NCT07058857 · Data updated 2026-11-12
This trial will see if low-level tragus stimulation applied near the ear can improve heart pumping and wall motion on echocardiogram in people with ST-elevation heart attacks treated with primary PCI.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Universitas Diponegoro Academic / other |
| Locations | 1 site (Semarang, Central of Java) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | September 1, 2025 |
| Study ends | September 30, 2025 |
| Registry record updated | July 10, 2025 |
| Trial ID | NCT07058857 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with ST-elevation myocardial infarction presenting within 12 hours, in sinus rhythm, hemodynamically stable (Killip I–II), and scheduled for primary PCI who consent to participate are the ideal candidates.
✕Probably not a fit
Patients with prior myocardial infarction or reduced ejection fraction, chronic severe comorbidities (advanced CKD, active malignancy, autoimmune or hematologic disease), permanent pacemaker, acute infection, pregnancy, or presentation beyond 12 hours are unlikely to be eligible or to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, randomized, sham-controlled interventional trial comparing low-level tragus stimulation (LLTS) to a sham LLTS in patients with STEMI undergoing primary percutaneous coronary intervention. Participants are randomized to active or sham Parasym neuromodulation and undergo transthoracic echocardiography before and after PPCI to measure left ventricular ejection fraction, wall motion score index, and diastolic parameters. The study also monitors safety signals related to LLTS in the acute STEMI setting. Outcomes will compare changes in echocardiographic parameters between the two groups to see if LLTS alters cardiac function after reperfusion.
Why it matters
Potential benefit: If successful, LLTS could help preserve or improve left ventricular function and wall motion after STEMI, which might lower the risk of subsequent heart failure.
How similar studies have gone: Small clinical and preclinical studies of auricular/vagal nerve stimulation indicate possible reductions in inflammation and myocardial injury, but direct evidence of benefit specifically after STEMI is limited and not yet conclusive.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Dr. Kariadi Central General Hospital
Semarang, Central of Java, Indonesia Recruiting
Study contacts
- Study coordinator: Leo Deddy Pradipta
- Email: dancingdeagle@gmail.com
- Phone: +6281316499074
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.