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Auricular Vagus Stimulation and STEMI

Primary Purpose

Vagus Nerve Stimulation, Acute Coronary Syndrome, Ischemia Reperfusion Injury

Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
TENS
Sponsored by
Bakulev Scientific Center of Cardiovascular Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vagus Nerve Stimulation focused on measuring auricular stimulation, auricular vagus nerve stimulation, transcutaneous vagus nerve stimulation (TENS), vagus nerve stimulation (VNS), acute coronary syndrome, myocardial ischemia reperfusion injury, ST-segment elevation myocardial infarction, coronary heart disease, acute myocardial infarction, mortality, atrial fibrillation

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patients with STEMI who have signed an informed voluntary consent to participate in the study; primary myocardial infarction; treatment in the first 12 hours from the onset of pain syndrome; primary PCI. Exclusion Criteria: acute heart failure III-IV; bradyarrhythmias; atrial fibrillation/flutter at the time of switching on; Thrombolytic therapy at the prehospital stage; a history of myocardial infarction; PCI/coronary artery bypass grafting (CABG) in the anamnesis.

Sites / Locations

  • Scientific Research Institute Ochapovsky Regional Clinical HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active TENS

Sham TENS

Arm Description

It will be performed attached to the tragus of the left ear.

It will be performed attached to the earlobe of the left ear.

Outcomes

Primary Outcome Measures

Hospital mortality
The number of patients who died in the hospital.
30-day mortality
The number of patients who died within 30 days from the development of myocardial infarction.

Secondary Outcome Measures

Number of participants with non-lethal events.
The main hospital non-lethal events (Pulmonary edema, Cardiogenic shock, Cardiac arrhythmias: Atrial fibrillation, Ventricular tachycardia/fibrillation, Accelerated idioventricular rhythm/Atrioventricular block II, III).

Full Information

First Posted
June 27, 2023
Last Updated
August 7, 2023
Sponsor
Bakulev Scientific Center of Cardiovascular Surgery
Collaborators
State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05992259
Brief Title
Auricular Vagus Stimulation and STEMI
Official Title
Auricular Vagus Stimulation and ST-Segment Elevation Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bakulev Scientific Center of Cardiovascular Surgery
Collaborators
State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
At the moment, the invasive strategy for the infarct-associated coronary artery in patients with ST-segment elevation myocardial infarction (STEMI) necessary to save the myocardium and reduce the size of the necrosis zone remains the leading one. However, despite the high efficiency of providing medical care to patients with acute coronary syndrome (ACS), there remains a high mortality and disability of this group of patients. In this regard, the search for new drug and non-drug strategies for the treatment of patients with ACS is actively continuing. Over the past decade, it has been shown that transcutaneous vagus nerve stimulation (TENS) has a cardioprotective effect both in chronic heart failure and in coronary heart disease, improves cardiac function, prevents reperfusion injury, weakens myocardial remodeling, increases the effectiveness of defibrillation and reduces the size of a heart attack. One of the methods of noninvasive stimulation of the afferent fibers of the vagus nerve is percutaneous electrical stimulation of the auricular branch of the vagus nerve. However, further studies are needed to determine whether stimulation of the tragus can improve the long-term clinical outcome in this cohort of patients.
Detailed Description
ACS is a combined concept for such life-threatening conditions as acute myocardial infarction (AMI) and unstable angina, which are exacerbations of coronary heart disease. However, despite the high effectiveness of the invasive treatment strategy, there remains a high mortality and disability of this group of patients. One of the reasons for this problem is reperfusion injury of the myocardium during revascularization, since reperfusion itself causes myocardial damage, known as Myocardial Ischemia Reperfusion Injury (MIRI). Every year, new data from experimental studies and small clinical trials appear, confirming the concept that MIRI makes a big contribution to the final size of a heart attack and cardiac myocardial function. Currently, there is no specific treatment aimed at MIRI in patients with STEMI. Thus, new treatment methods are needed that can reduce MIRI in revascularized patients. In the course of small clinical studies, it was shown that against the background of vagus nerve stimulation, a significant decrease in heart rate occurs, inflammatory processes and cellular apoptosis are suppressed, left ventricular remodeling decreases and myocardial contractile function improves. Also, a significant decrease in MIRI is demonstrated with percutaneous stimulation of the vagus nerve in the acute period of myocardial infarction. The data of the first clinical trial with VNS in patients with STEMI were published in 2017 (doi:10.1016/j.jcin.2017.04.036). This experimental study increases the likelihood that this noninvasive therapy can be used to treat patients with STEMI who are undergoing primary percutaneous coronary intervention (PCI). New studies are needed to prove the safety and effectiveness of vagus nerve stimulation in patients with STEMI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vagus Nerve Stimulation, Acute Coronary Syndrome, Ischemia Reperfusion Injury
Keywords
auricular stimulation, auricular vagus nerve stimulation, transcutaneous vagus nerve stimulation (TENS), vagus nerve stimulation (VNS), acute coronary syndrome, myocardial ischemia reperfusion injury, ST-segment elevation myocardial infarction, coronary heart disease, acute myocardial infarction, mortality, atrial fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 randomization of active stimulation vs. sham stimulation
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active TENS
Arm Type
Active Comparator
Arm Description
It will be performed attached to the tragus of the left ear.
Arm Title
Sham TENS
Arm Type
Sham Comparator
Arm Description
It will be performed attached to the earlobe of the left ear.
Intervention Type
Device
Intervention Name(s)
TENS
Intervention Description
TENS will be performed from the moment of admission to the PCI, during the PCI and for the next 30 minutes after it.
Primary Outcome Measure Information:
Title
Hospital mortality
Description
The number of patients who died in the hospital.
Time Frame
From date of randomization until the date of death from any cause, assessed up to 14 days.
Title
30-day mortality
Description
The number of patients who died within 30 days from the development of myocardial infarction.
Time Frame
From date of randomization until the date of death from any cause, assessed up to 30 days.
Secondary Outcome Measure Information:
Title
Number of participants with non-lethal events.
Description
The main hospital non-lethal events (Pulmonary edema, Cardiogenic shock, Cardiac arrhythmias: Atrial fibrillation, Ventricular tachycardia/fibrillation, Accelerated idioventricular rhythm/Atrioventricular block II, III).
Time Frame
From the date of randomization to the date of any of the listed events, assessed up to 14 days.
Other Pre-specified Outcome Measures:
Title
Assessment of the level of myocardial damage.
Description
Dynamics of Troponin I (hs-cTnI) in blood plasma.
Time Frame
Diagnosis will be carried out during hospitalization, after 6 hours and on the 4th day of hospitalization.
Title
Assessment of the level of inflammation.
Description
Dynamics of high-sensitivity C-reactive protein (hs-CRP) in blood plasma. Dynamics of copeptin (CPP) in blood plasma.
Time Frame
Diagnosis will be carried out during hospitalization and after 24 hours.
Title
Assessment of the level of heart failure
Description
Dynamics of NT-proBNP in blood plasma.
Time Frame
Diagnosis will be carried out during hospitalization and on the 4th day of hospitalization.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with STEMI who have signed an informed voluntary consent to participate in the study; primary myocardial infarction; treatment in the first 12 hours from the onset of pain syndrome; primary PCI. Exclusion Criteria: acute heart failure III-IV; bradyarrhythmias; atrial fibrillation/flutter at the time of switching on; Thrombolytic therapy at the prehospital stage; a history of myocardial infarction; PCI/coronary artery bypass grafting (CABG) in the anamnesis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vladimir Shvartz, MD, DM
Phone
+79032619292
Email
vashvarts@bakulev.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vladimir Shvartz, MD, DM
Organizational Affiliation
Bakoulev Scientific Center for Cardiovascular Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scientific Research Institute Ochapovsky Regional Clinical Hospital
City
Krasnodar
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sofia Kruchinova, MD, PhD
Phone
+79189504597
Email
skruchinova@mail.ru

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://doi.org/10.1016/j.jcin.2017.04.036
Description
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
URL
https://doi.org/10.1016/j.jcin.2017.05.063
Description
Vagal Cardioprotection in Reperfused Acute Myocardial Infarction

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Auricular Vagus Stimulation and STEMI

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