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RecruitingNCT07058857ELITE-STEMIUpdated Jul 10, 2025

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

An interventional study of Parasym Neuromodulation Device (Treatment Group) and Parasym Neuromodulation Device (Sham Group) in ST Elevation Myocardial Infarction, sponsored by Universitas Diponegoro. Recruiting at 1 site in Indonesia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-07-10.

Sponsored by Universitas Diponegoro · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Registered 5 months after the study started (first participant enrolled Jan 2025, registered Jun 2025).
  • Started Jan 2025; still recruiting 1 year 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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..

02

Conditions studied

  • ST Elevation Myocardial Infarction

Keywords

  • ST-segment elevation myocardial infarction
  • Low level tragus stimulation
  • Left ventricular ejection fraction
  • Wall motion score index
03

In context

ST Elevation Myocardial Infarction

667 studies on the registry are indexed under ST Elevation Myocardial Infarction; 180 are open to participants now.

This study's planned enrollment of 100 is below the median of 194 across 427 interventional studies indexed under ST Elevation Myocardial Infarction.

Browse ST Elevation Myocardial Infarction studies →

Lead sponsor

Universitas Diponegoro is the lead sponsor of 23 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Low Level Tragus Stimulation Group

    Participant will undergo low level tragus stimulation using Parasym Device

    Device: Parasym Neuromodulation Device (Treatment Group) · Device: Parasym Neuromodulation Device (Sham Group)

  • Sham comparator
    Sham Control Group

    Participant will have Parasym Device implanted in their tragus without any active stimulation from the device

    Device: Parasym Neuromodulation Device (Treatment Group) · Device: Parasym Neuromodulation Device (Sham Group)

Interventions

  • DeviceParasym Neuromodulation Device (Treatment Group)

    Participant will undergo stimulation in their left tragus for 60 minutes by using Parasym device

  • DeviceParasym Neuromodulation Device (Sham Group)

    Participant will undergo implantation of Parasym device lead in their left tragus but without any stimulation for 60 minutes

06

What researchers measure

Primary outcomes

  1. Left Ventricular Ejection Fraction

    Left Ventricular Ejection Fraction measured by transthoracic echocardiography

    Time frame: Before PPCI, 1 day after PPCI, and 30 days after PPCI

Secondary outcomes

  1. Wall Motion Score Index

    Wall Motion Score Index measured by transthoracic echocardiography

    Time frame: Before PPCI, 1 day after PPCI, and 30 days after PPCI

  2. Diastolic Function

    Diastolic Function measured by transthoracic echocardiography

    Time frame: Before PPCI, 1 day after PPCI, and 30 days after PPCI

07

Study locations

1 of 1 sites recruiting
  • Dr. Kariadi Central General Hospital
    Semarang, Central of Java, Indonesia
    Recruiting
08

References and documents

Publications

  • Yu L, Huang B, Po SS, Tan T, Wang M, Zhou L, Meng G, Yuan S, Zhou X, Li X, Wang Z, Wang S, Jiang H. Low-Level Tragus Stimulation for the Treatment of Ischemia and Reperfusion Injury in Patients With ST-Segment Elevation Myocardial Infarction: A Proof-of-Concept Study. JACC Cardiovasc Interv. 2017 Aug 14;10(15):1511-1520. doi: 10.1016/j.jcin.2017.04.036. PubMed 28797427 ↗
  • Redgrave J, Day D, Leung H, Laud PJ, Ali A, Lindert R, Majid A. Safety and tolerability of Transcutaneous Vagus Nerve stimulation in humans; a systematic review. Brain Stimul. 2018 Nov-Dec;11(6):1225-1238. doi: 10.1016/j.brs.2018.08.010. Epub 2018 Aug 23. PubMed 30217648 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07058857
Lead sponsor
Universitas Diponegoro
Responsible party
Sodiqur Rifqi (Principal Investigator; Former of Head of Department of Cardiovascular Medicine Faculty of Medicine Universitas Diponegoro, Universitas Diponegoro) — Principal investigator
First posted
Jul 10, 2025
Start date
Jan 1, 2025
Primary completion
Sep 1, 2025 (estimated)
Completion
Sep 30, 2025 (estimated)
Last update
Jul 10, 2025

Study contacts

Leo Deddy Pradipta
Contact
dancingdeagle@gmail.com
+6281316499074

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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