Auricular Vagus Stimulation and STEMI

Sponsor

Bakulev Scientific Center of Cardiovascular Surgery (Other)

Overall Status

Recruiting

CT.gov ID

NCT05992259

Collaborator

State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital (Other)

300

Enrollment

Location

Arms

Anticipated Duration (Months)

7.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Vagus Nerve Stimulation Acute Coronary Syndrome Ischemia Reperfusion Injury	Device: TENS	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

1:1 randomization of active stimulation vs. sham stimulation1:1 randomization of active stimulation vs. sham stimulation

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Auricular Vagus Stimulation and ST-Segment Elevation Myocardial Infarction

Actual Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Sep 30, 2024

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Active TENS It will be performed attached to the tragus of the left ear.	Device: TENS TENS will be performed from the moment of admission to the PCI, during the PCI and for the next 30 minutes after it.
Sham Comparator: Sham TENS It will be performed attached to the earlobe of the left ear.	Device: TENS TENS will be performed from the moment of admission to the PCI, during the PCI and for the next 30 minutes after it.

Arm

Intervention/Treatment

Active Comparator: Active TENS

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

Device: TENS

TENS will be performed from the moment of admission to the PCI, during the PCI and for the next 30 minutes after it.

Sham Comparator: Sham TENS

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

Device: TENS

TENS will be performed from the moment of admission to the PCI, during the PCI and for the next 30 minutes after it.

Outcome Measures

Primary Outcome Measures

Hospital mortality [From date of randomization until the date of death from any cause, assessed up to 14 days.]
The number of patients who died in the hospital.
30-day mortality [From date of randomization until the date of death from any cause, assessed up to 30 days.]
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. [From the date of randomization to the date of any of the listed events, assessed up to 14 days.]
The main hospital non-lethal events (Pulmonary edema, Cardiogenic shock, Cardiac arrhythmias: Atrial fibrillation, Ventricular tachycardia/fibrillation, Accelerated idioventricular rhythm/Atrioventricular block II, III).

Other Outcome Measures

Assessment of the level of myocardial damage. [Diagnosis will be carried out during hospitalization, after 6 hours and on the 4th day of hospitalization.]
Dynamics of Troponin I (hs-cTnI) in blood plasma.
Assessment of the level of inflammation. [Diagnosis will be carried out during hospitalization and after 24 hours.]
Dynamics of high-sensitivity C-reactive protein (hs-CRP) in blood plasma. Dynamics of copeptin (CPP) in blood plasma.
Assessment of the level of heart failure [Diagnosis will be carried out during hospitalization and on the 4th day of hospitalization.]
Dynamics of NT-proBNP in blood plasma.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Scientific Research Institute Ochapovsky Regional Clinical Hospital	Krasnodar		Russian Federation

Sponsors and Collaborators

Bakulev Scientific Center of Cardiovascular Surgery
State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital