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 (TESLA-STEMI)
TESLA-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 heart rate variability (HRV), neutrophil-lymphocyte ratio, and major adverse cardiovascular events in patient with ST-segment Elevation Myocardial Infarction (STEMI). It will also learn about the safety of LLTS in such setting. The main questions, it aims to answer are compared with sham control:
- 1.Does LLTS could alter low frequency/high frequency ratio in patients with STEMI?
- 2.Does LLTS could alter neutrophil-lymphocyte ratio in patients with STEMI?
- 3.Does LLTS could decrease mortality in patients with STEMI?
- 4.Does LLTS could decrease reinfarction event in patients with STEMI?
- 5.Does LLTS could decrease stroke event in patients with STEMI?
- 6.Does LLTS could decrease lethal arrhythmia event in patients with STEMI?
- 7.Does LLTS could decrease acute lung oedema event in patients with STEMI?
- 8.Does LLTS could decrease cardiogenic shock event in patients with STEMI?
- 9.Undergo laboratory examination before Primary Percutaneous Coronary Intervention (PPCI)
- 10.Undergo HRV measurement using WeCardio device before Primary Percutaneous Coronary Intervention (PPCI)
- 11.Undergo LLTS (treatment group will have stimulation) for 60 minutes, however, sham control will not have stimulation, before PPCI
- 12.Undergo PPCI
- 13.Undergo laboratory examination after Primary Percutaneous Coronary Intervention (PPCI)
- 14.Undergo HRV measurement using WeCardio device after Primary Percutaneous Coronary Intervention (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 2024
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, 2024
CompletedFirst Submitted
Initial submission to the registry
July 24, 2024
CompletedFirst Posted
Study publicly available on registry
August 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedAugust 5, 2024
July 1, 2024
8 months
July 24, 2024
July 31, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major Adverse Cardiovascular Events
Consist of mortality, reinfarction, stroke, lethal arrhtyhmia, acute lung oedema, cardiogenic shock
During hospitalization around up to 1 weeks
Secondary Outcomes (2)
Heart Rate Variability
Before and After LLTS and Primary PCI (approximately within 24 to 48 hours after PPCI)
Neutrophil-Lymphocyte Ratio
Before and After LLTS and Primary PCI (approximately within 24 to 48 hours 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
July 24, 2024
First Posted
August 5, 2024
Study Start
January 1, 2024
Primary Completion
August 31, 2024
Study Completion
September 30, 2024
Last Updated
August 5, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share