Auricular Vagus Stimulation and STEMI

Acute Coronary Syndrome Clinical Trial

Official title:

Auricular Vagus Stimulation and ST-Segment Elevation Myocardial Infarction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05992259
• Other study ID #: #12
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 1, 2025

Study information

• Verified date: August 2023
• Source: Bakulev Scientific Center of Cardiovascular Surgery
• Contact: Vladimir Shvartz, MD, DM
• Phone: +79032619292
• Email: vashvarts[@]bakulev.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 1, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Ischemia
• Ischemia Reperfusion Injury
• Myocardial Infarction
• Reperfusion Injury
• ST Elevation Myocardial Infarction
• Vagus Nerve Stimulation

Intervention

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.

Locations

Country	Name	City	State
Russian Federation	Scientific Research Institute Ochapovsky Regional Clinical Hospital	Krasnodar

Sponsors (2)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of the level of myocardial damage.	Dynamics of Troponin I (hs-cTnI) in blood plasma.	Diagnosis will be carried out during hospitalization, after 6 hours and on the 4th day of hospitalization.
Other	Assessment of the level of inflammation.	Dynamics of high-sensitivity C-reactive protein (hs-CRP) in blood plasma. Dynamics of copeptin (CPP) in blood plasma.	Diagnosis will be carried out during hospitalization and after 24 hours.
Other	Assessment of the level of heart failure	Dynamics of NT-proBNP in blood plasma.	Diagnosis will be carried out during hospitalization and on the 4th day of hospitalization.
Primary	Hospital mortality	The number of patients who died in the hospital.	From date of randomization until the date of death from any cause, assessed up to 14 days.
Primary	30-day mortality	The number of patients who died within 30 days from the development of myocardial infarction.	From date of randomization until the date of death from any cause, assessed up to 30 days.
Secondary	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).	From the date of randomization to the date of any of the listed events, assessed up to 14 days.

External Links

•   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
•   Vagal Cardioprotection in Reperfused Acute Myocardial Infarction