Low-level tragus stimulation for heart health in heart attack patients
The Efficacy and Safety of Low-Level Tragus Stimulation on Heart Rate Variability, Neutrophil-Lymphocyte Ratio, and Major Adverse Cardiovascular Events in Patients With ST-Segment Elevation Myocardial Infarction
This study is testing if low-level stimulation of the tragus can help heart attack patients improve their heart health and reduce serious complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Universitas Diponegoro Academic / other |
| Locations | 1 site (Semarang, Central of Java) |
| Trial ID | NCT06537583 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of low-level tragus stimulation (LLTS) on heart rate variability, neutrophil-lymphocyte ratio, and major adverse cardiovascular events in patients experiencing ST-segment elevation myocardial infarction (STEMI). Participants will be randomly assigned to receive either LLTS or a sham treatment, and the study aims to determine if LLTS can improve cardiovascular outcomes and safety in this patient population. Key outcomes include changes in heart rate variability, mortality rates, and incidences of reinfarction, stroke, and other serious events. The trial will also assess the safety profile of LLTS in the context of STEMI.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with STEMI within 12 hours of onset, who are in Killip class I-II and have stable blood pressure.
Not a fit: Patients with a history of significant cardiovascular issues, chronic diseases, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved heart health and reduced complications for patients recovering from heart attacks.
How similar studies have performed: While the specific application of LLTS in STEMI is novel, similar neuromodulation techniques have shown promise in other cardiovascular contexts.
Eligibility criteria
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 this trial is running
Semarang, Central of Java
- Dr. Kariadi Central General Hospital — Semarang, Central of Java, Indonesia (Recruiting)
Study contacts
- Study coordinator: Leo Deddy Pradipta
- Email: dancingdeagle@gmail.com
- Phone: +6281316499074
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.