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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Level Tragus Stimulation Group | Experimental | Participant will undergo low level tragus stimulation using Parasym Device |
|
| Sham Control Group | Sham Comparator | Participant will have Parasym Device implanted in their tragus without any active stimulation from the device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parasym Neuromodulation Device (Treatment Group) | Device | Participant will undergo stimulation in their left tragus for 60 minutes by using Parasym device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiovascular Events | Consist of mortality, reinfarction, stroke, lethal arrhtyhmia, acute lung oedema, cardiogenic shock | During hospitalization around up to 1 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate Variability | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leo Deddy Pradipta | Contact | +6281316499074 | dancingdeagle@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Kariadi Central General Hospital | Recruiting | Semarang | Central of Java | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28797427 | Background | 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. | |
| 30217648 |
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Participant will not know either they include in treatment or control group
| Parasym Neuromodulation Device (Sham Group) | Device | Participant will undergo implantation of Parasym device lead in their left tragus but without any stimulation for 60 minutes |
|
Neutrophil-Lymphocyte Ratio from laboratory findings
| Before and After LLTS and Primary PCI (approximately within 24 to 48 hours after PPCI) |
| 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. |
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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