Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06537583
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief 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 TESLA-STEMI
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TESLA-STEMI
Brief 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 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 frequencyhigh 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 ie treatment group vs control shamplacebo 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
1 Does LLTS could alter low frequencyhigh 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 ie treatment group vs control shamplacebo 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None