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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..
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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 |
|---|---|---|
| Left Ventricular Ejection Fraction | Left Ventricular Ejection Fraction measured by transthoracic echocardiography | Before PPCI, 1 day after PPCI, and 30 days after PPCI |
| Measure | Description | Time Frame |
|---|---|---|
| Wall Motion Score Index | Wall Motion Score Index measured by transthoracic echocardiography | Before PPCI, 1 day after PPCI, and 30 days after PPCI |
| Diastolic Function | Diastolic Function measured by transthoracic echocardiography |
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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 |
|
| Before PPCI, 1 day after PPCI, and 30 days 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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