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) (TESLA-STEMI)

July 31, 2024 updated by: Sodiqur Rifqi, Universitas Diponegoro

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

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:

  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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Indonesia
    • Central Of Java
      • Semarang, Central Of Java, Indonesia
        • Recruiting
        • Dr. Kariadi Central General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low Level Tragus Stimulation Group
Participant will undergo low level tragus stimulation using Parasym Device
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
Sham Comparator: Sham Control Group
Participant will have Parasym Device implanted in their tragus without any active stimulation from the device
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiovascular Events
Time Frame: During hospitalization around up to 1 weeks
Consist of mortality, reinfarction, stroke, lethal arrhtyhmia, acute lung oedema, cardiogenic shock
During hospitalization around up to 1 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate Variability
Time Frame: Before and After LLTS and Primary PCI (approximately within 24 to 48 hours after PPCI)
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
Time Frame: Before and After LLTS and Primary PCI (approximately within 24 to 48 hours after PPCI)
Neutrophil-Lymphocyte Ratio from laboratory findings
Before and After LLTS and Primary PCI (approximately within 24 to 48 hours after PPCI)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Diponegoro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

July 24, 2024

First Submitted That Met QC Criteria

July 31, 2024

First Posted (Estimated)

August 5, 2024

Study Record Updates

Last Update Posted (Estimated)

August 5, 2024

Last Update Submitted That Met QC Criteria

July 31, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Undip

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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