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Recruiting NCT07058857

NCT07058857 The Effect of Low-Level Tragus Stimulation on Echocardiographic Parameters in Patients With ST-Segment Elevation Myocardial Infarction - A Single-Centre Randomized Control Trial

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Clinical Trial Summary
NCT ID NCT07058857
Status Recruiting
Phase
Sponsor Universitas Diponegoro
Condition ST Elevation Myocardial Infarction
Study Type INTERVENTIONAL
Enrollment 100 participants
Start Date 2025-01-01
Primary Completion 2025-09-01

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 75 Years
Study Type INTERVENTIONAL
Interventions
Parasym Neuromodulation Device (Treatment Group)Parasym Neuromodulation Device (Sham Group)

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 100 participants in total. It began in 2025-01-01 with a primary completion date of 2025-09-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

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..

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

Contact & Investigator

Central Contact

Leo Deddy Pradipta

✉ dancingdeagle@gmail.com

📞 +6281316499074

Frequently Asked Questions

Who can join the NCT07058857 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying ST Elevation Myocardial Infarction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07058857 currently recruiting?

Yes, NCT07058857 is actively recruiting participants. Contact the research team at dancingdeagle@gmail.com for enrollment information.

Where is the NCT07058857 trial being conducted?

This trial is being conducted at Semarang, Indonesia.

Who is sponsoring the NCT07058857 clinical trial?

NCT07058857 is sponsored by Universitas Diponegoro. The trial plans to enroll 100 participants.

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