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)
July 31, 2024 updated by: Sodiqur Rifqi, Universitas Diponegoro
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
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:
- Does LLTS could alter low frequency/high frequency ratio in patients with STEMI?
- Does LLTS could alter neutrophil-lymphocyte ratio in patients with STEMI?
- Does LLTS could decrease mortality in patients with STEMI?
- Does LLTS could decrease reinfarction event in patients with STEMI?
- Does LLTS could decrease stroke event in patients with STEMI?
- Does LLTS could decrease lethal arrhythmia event in patients with STEMI?
- Does LLTS could decrease acute lung oedema event in patients with STEMI?
- Does LLTS could decrease cardiogenic shock event 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, then both of them:
- Undergo laboratory examination before Primary Percutaneous Coronary Intervention (PPCI)
- Undergo HRV measurement using WeCardio device before Primary Percutaneous Coronary Intervention (PPCI)
- Undergo LLTS (treatment group will have stimulation) for 60 minutes, however, sham control will not have stimulation, before PPCI
- Undergo PPCI
- Undergo laboratory examination after Primary Percutaneous Coronary Intervention (PPCI)
- Undergo HRV measurement using WeCardio device after Primary Percutaneous Coronary Intervention (PPCI)
Study Overview
Status
Recruiting
Conditions
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Leo Deddy Pradipta
- Phone Number: +6281316499074
- Email: dancingdeagle@gmail.com
Study Locations
-
-
Central Of Java
-
Semarang, Central Of Java, Indonesia
- Recruiting
- Dr. Kariadi Central General Hospital
-
Contact:
- Leo Deddy Pradipta
- Phone Number: +6281316499074
- Email: dancingdeagle@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Low Level Tragus Stimulation Group
Participant will undergo low level tragus stimulation using Parasym Device
|
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
|
|
Sham Comparator: Sham Control Group
Participant will have Parasym Device implanted in their tragus without any active stimulation from the device
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Major Adverse Cardiovascular Events
Time Frame: During hospitalization around up to 1 weeks
|
Consist of mortality, reinfarction, stroke, lethal arrhtyhmia, acute lung oedema, cardiogenic shock
|
During hospitalization around up to 1 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart Rate Variability
Time Frame: Before and After LLTS and Primary PCI (approximately within 24 to 48 hours after PPCI)
|
Heart Rate Variability measurement by using WeCardio device
|
Before and After LLTS and Primary PCI (approximately within 24 to 48 hours after PPCI)
|
|
Neutrophil-Lymphocyte Ratio
Time Frame: Before and After LLTS and Primary PCI (approximately within 24 to 48 hours after PPCI)
|
Neutrophil-Lymphocyte Ratio from laboratory findings
|
Before and After LLTS and Primary PCI (approximately within 24 to 48 hours after PPCI)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2024
Primary Completion (Estimated)
August 31, 2024
Study Completion (Estimated)
September 30, 2024
Study Registration Dates
First Submitted
July 24, 2024
First Submitted That Met QC Criteria
July 31, 2024
First Posted (Estimated)
August 5, 2024
Study Record Updates
Last Update Posted (Estimated)
August 5, 2024
Last Update Submitted That Met QC Criteria
July 31, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Undip
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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