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)
NCT ID: NCT06537583
Last Updated: 2024-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2024-01-01
2024-09-30
Brief Summary
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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?
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:
1. Undergo laboratory examination before Primary Percutaneous Coronary Intervention (PPCI)
2. Undergo HRV measurement using WeCardio device before Primary Percutaneous Coronary Intervention (PPCI)
3. Undergo LLTS (treatment group will have stimulation) for 60 minutes, however, sham control will not have stimulation, before PPCI
4. Undergo PPCI
5. Undergo laboratory examination after Primary Percutaneous Coronary Intervention (PPCI)
6. Undergo HRV measurement using WeCardio device after Primary Percutaneous Coronary Intervention (PPCI)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Low Level Tragus Stimulation Group
Participant will undergo low level tragus stimulation using Parasym Device
Parasym Neuromodulation Device (Treatment Group)
Participant will undergo stimulation in their left tragus for 60 minutes by using Parasym device
Parasym Neuromodulation Device (Sham Group)
Participant will undergo implantation of Parasym device lead in their left tragus but without any stimulation for 60 minutes
Sham Control Group
Participant will have Parasym Device implanted in their tragus without any active stimulation from the device
Parasym Neuromodulation Device (Treatment Group)
Participant will undergo stimulation in their left tragus for 60 minutes by using Parasym device
Parasym Neuromodulation Device (Sham Group)
Participant will undergo implantation of Parasym device lead in their left tragus but without any stimulation for 60 minutes
Interventions
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Parasym Neuromodulation Device (Treatment Group)
Participant will undergo stimulation in their left tragus for 60 minutes by using Parasym device
Parasym Neuromodulation Device (Sham Group)
Participant will undergo implantation of Parasym device lead in their left tragus but without any stimulation for 60 minutes
Eligibility Criteria
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Inclusion Criteria
* 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
* On permanent pacemaker
* Acute infection
* Pregnant woman
18 Years
70 Years
ALL
No
Sponsors
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Universitas Diponegoro
OTHER
Responsible Party
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Sodiqur Rifqi
Principal Investigator; Former of Head of Department of Cardiovascular Medicine Faculty of Medicine Universitas Diponegoro
Locations
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Dr. Kariadi Central General Hospital
Semarang, Central of Java, Indonesia
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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Undip
Identifier Type: -
Identifier Source: org_study_id
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