The Effect of Low-Level Tragus Stimulation on Echocardiographic Parameters in Patients With ST-Segment Elevation Myocardial Infarction - A Single-Centre Randomized Control Trial
ELITE-STEMI
1 other identifier
interventional
100
1 country
1
Brief 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..
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2025
CompletedFirst Submitted
Initial submission to the registry
June 30, 2025
CompletedFirst Posted
Study publicly available on registry
July 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2025
CompletedJuly 10, 2025
June 1, 2025
8 months
June 30, 2025
June 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Left Ventricular Ejection Fraction
Left Ventricular Ejection Fraction measured by transthoracic echocardiography
Before PPCI, 1 day after PPCI, and 30 days after PPCI
Secondary Outcomes (2)
Wall Motion Score Index
Before PPCI, 1 day after PPCI, and 30 days after PPCI
Diastolic Function
Before PPCI, 1 day after PPCI, and 30 days after PPCI
Study Arms (2)
Low Level Tragus Stimulation Group
EXPERIMENTALParticipant will undergo low level tragus stimulation using Parasym Device
Sham Control Group
SHAM COMPARATORParticipant will have Parasym Device implanted in their tragus without any active stimulation from the device
Interventions
Participant will undergo stimulation in their left tragus for 60 minutes by using Parasym device
Participant will undergo implantation of Parasym device lead in their left tragus but without any stimulation for 60 minutes
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr. Kariadi Central General Hospital
Semarang, Central of Java, Indonesia
Related Publications (2)
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.
PMID: 28797427BACKGROUNDRedgrave 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.
PMID: 30217648BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participant will not know either they include in treatment or control group
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator; Former of Head of Department of Cardiovascular Medicine Faculty of Medicine Universitas Diponegoro
Study Record Dates
First Submitted
June 30, 2025
First Posted
July 10, 2025
Study Start
January 1, 2025
Primary Completion
September 1, 2025
Study Completion
September 30, 2025
Last Updated
July 10, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share