ST Elevation Myocardial InfarctionTESLA-STEMINCT06537583
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)
A study testing Parasym Neuromodulation Device (Treatment Group) in people with ST Elevation Myocardial Infarction, run by Universitas Diponegoro at 1 site in Indonesia.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- ST Elevation Myocardial Infarction
- What is being tested?
- Parasym Neuromodulation Device (Treatment Group)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2024to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
Dr. Kariadi Central General Hospital
Semarang, Central of Java
Leo Deddy Pradipta, +6281316499074, dancingdeagle@gmail.com
About this study
Official title: 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:
- Does LLTS could alter low frequency/high frequency ratio in patients with STEMI?
- Does LLTS could alter neutrophil-lymphocyte ratio in patients with STEMI?
- Does LLTS could decrease mortality in patients with STEMI?
- Does LLTS could decrease reinfarction event in patients with STEMI?
- Does LLTS could decrease stroke event in patients with STEMI?
- Does LLTS could decrease lethal arrhythmia event in patients with STEMI?
- Does LLTS could decrease acute lung oedema event in patients with STEMI?
- Does LLTS could decrease cardiogenic shock event in patients with STEMI?
Read more
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:
- Undergo laboratory examination before Primary Percutaneous Coronary Intervention (PPCI)
- Undergo HRV measurement using WeCardio device before Primary Percutaneous Coronary Intervention (PPCI)
- Undergo LLTS (treatment group will have stimulation) for 60 minutes, however, sham control will not have stimulation, before PPCI
- Undergo PPCI
- Undergo laboratory examination after Primary Percutaneous Coronary Intervention (PPCI)
- Undergo HRV measurement using WeCardio device after Primary Percutaneous Coronary Intervention (PPCI)
- Conditions
- ST Elevation Myocardial Infarction
- Being tested
- Parasym Neuromodulation Device (Treatment Group), Parasym Neuromodulation Device (Sham Group)
- Keywords
- ST segment elevation myocardial infarction, Low level tragus stimulation, Heart rate variability, Neutrophil-lymphocyte ratio, Major adverse cardiovascular events
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parasym Neuromodulation Device (Treatment Group)Device
Participant will undergo stimulation in their left tragus for 60 minutes by using Parasym device
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
| Study group | Role | What they receive |
|---|---|---|
| Low Level Tragus Stimulation Group | Experimental | Participant will undergo low level tragus stimulation using Parasym Device Receives: Device: Parasym Neuromodulation Device (Treatment Group); Device: Parasym Neuromodulation Device (Sham Group) |
| Sham Control Group | Sham comparator | Participant will have Parasym Device implanted in their tragus without any active stimulation from the device Receives: Device: Parasym Neuromodulation Device (Treatment Group); Device: Parasym Neuromodulation Device (Sham Group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events
Consist of mortality, reinfarction, stroke, lethal arrhtyhmia, acute lung oedema, cardiogenic shock
Measured: During hospitalization around up to 1 weeks
Secondary outcomes (2)
Heart Rate Variability
Heart Rate Variability measurement by using WeCardio device
Measured: Before and After LLTS and Primary PCI (approximately within 24 to 48 hours after PPCI)
Neutrophil-Lymphocyte Ratio
Neutrophil-Lymphocyte Ratio from laboratory findings
Measured: Before and After LLTS and Primary PCI (approximately within 24 to 48 hours after PPCI)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start1 Jan 2024
- Primary completion31 Aug 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Diponegoro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sodiqur Rifqi, Universitas Diponegoro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537583
- Sponsor's protocol ID
- Undip
- Acronym
- TESLA-STEMI
- Status last verified
- Jul 2024
- First submitted
- 24 Jul 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28797427Redgrave 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.
PubMed 30217648
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06537583
- Acronym / sponsor ID
- TESLA-STEMI / Undip
- Conditions
- ST Elevation Myocardial Infarction
- Keywords
- ST segment elevation myocardial infarction, Low level tragus stimulation, Heart rate variability, Neutrophil-lymphocyte ratio, Major adverse cardiovascular events
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitas DiponegoroUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Aug 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does LLTS could alter low frequency/high frequency ratio in patients with STEMI?
- Does LLTS could alter neutrophil-lymphocyte ratio in patients with STEMI?
- Does LLTS could decrease mortality in patients with STEMI?
- Does LLTS could decrease reinfarction event in patients with STEMI?
- Does LLTS could decrease stroke event in patients with STEMI?
- Does LLTS could decrease lethal arrhythmia event in patients with STEMI?
- Does LLTS could decrease acute lung oedema event in patients with STEMI?
- 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:
- Undergo laboratory examination before Primary Percutaneous Coronary Intervention (PPCI)
- Undergo HRV measurement using WeCardio device before Primary Percutaneous Coronary Intervention (PPCI)
- Undergo LLTS (treatment group will have stimulation) for 60 minutes, however, sham control will not have stimulation, before PPCI
- Undergo PPCI
- Undergo laboratory examination after Primary Percutaneous Coronary Intervention (PPCI)
- Undergo HRV measurement using WeCardio device after Primary Percutaneous Coronary Intervention (PPCI)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Level Tragus Stimulation Group | Experimental | Device: Parasym Neuromodulation Device (Treatment Group), Device: Parasym Neuromodulation Device (Sham Group)Participant will undergo low level tragus stimulation using Parasym Device |
| Sham Control Group | Sham comparator | Device: Parasym Neuromodulation Device (Treatment Group), Device: Parasym Neuromodulation Device (Sham Group)Participant will have Parasym Device implanted in their tragus without any active stimulation from the device |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parasym Neuromodulation Device (Treatment Group)Participant will undergo stimulation in their left tragus for 60 minutes by using Parasym device | Device | Low Level Tragus Stimulation Group, Sham Control Group |
| Parasym Neuromodulation Device (Sham Group)Participant will undergo implantation of Parasym device lead in their left tragus but without any stimulation for 60 minutes | Device | Low Level Tragus Stimulation Group, Sham Control Group |
Primary outcome
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
2 secondary outcomes
Heart Rate Variability
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Background: PubMed 28797427Yu 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.
- Background: PubMed 30217648Redgrave 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parasym Neuromodulation Device (Treatment Group) in people with ST Elevation Myocardial Infarction, run by Universitas Diponegoro at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leo Deddy Pradipta (+6281316499074, dancingdeagle@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events (time frame: During hospitalization around up to 1 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06537583, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.