Clinical trial NCT05992259: Auricular Vagus Stimulation and STEMI
Official title: Auricular Vagus Stimulation and ST-Segment Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: Bakulev Scientific Center of Cardiovascular Surgery
Sponsor class: OTHER_GOV
Collaborators: name: State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital
First posted: 2023-08-15
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomization of active stimulation vs. sham stimulation
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Hospital mortality
timeFrame: From date of randomization until the date of death from any cause, assessed up to 14 days.
measure: 30-day mortality
timeFrame: From date of randomization until the date of death from any cause, assessed up to 30 days.
Secondary outcomes:
measure: Number of participants with non-lethal events.
timeFrame: From the date of randomization to the date of any of the listed events, assessed up to 14 days.
Other outcomes:
measure: Assessment of the level of myocardial damage.
timeFrame: Diagnosis will be carried out during hospitalization, after 6 hours and on the 4th day of hospitalization.
measure: Assessment of the level of inflammation.
timeFrame: Diagnosis will be carried out during hospitalization and after 24 hours.
measure: Assessment of the level of heart failure
timeFrame: Diagnosis will be carried out during hospitalization and on the 4th day of hospitalization.
Locations:
city: Krasnodar
country: Russian Federation
facility: Scientific Research Institute Ochapovsky Regional Clinical Hospital
Study officials:
affiliation: Bakoulev Scientific Center for Cardiovascular Surgery
name: Vladimir Shvartz, MD, DM
role: PRINCIPAL_INVESTIGATOR
References: