The Effect of Low-Level Tragus Stimulation on Echocardiographic Parameters in Patients With ST-Segment Elevation Myocardial Infarction - A Single-Centre Randomized Control Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Parasym Neuromodulation Device (Treatment Group), Parasym Neuromodulation Device (Sham Group).
- Who it may be relevant to
- Registry conditions: ST Elevation Myocardial Infarction. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Indonesia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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..
Interventions
- Device Parasym Neuromodulation Device (Treatment Group)
Participant will undergo stimulation in their left tragus for 60 minutes by using Parasym device - 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
Primary outcome measures
- Left Ventricular Ejection Fraction [Time frame: Before PPCI, 1 day after PPCI, and 30 days after PPCI]
Secondary outcome measures (2)
- Wall Motion Score Index [Time frame: Before PPCI, 1 day after PPCI, and 30 days after PPCI]
- Diastolic Function [Time frame: Before PPCI, 1 day after PPCI, and 30 days after PPCI]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Indonesia · 1 center
- Dr. Kariadi Central General Hospital — Semarang
Publications
- 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 28797427
- 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. PMID 30217648
Identifiers
NCT: NCT07058857 · Undip_Kardio 5