Auricular Vagus Stimulation and STEMI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorBakulev Scientific Center of Cardiovascular Surgery
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
acute heart failure III-IV;
bradyarrhythmias;
atrial fibrillation/flutter at the time of switching on;
Thrombolytic therapy at the prehospital stage;
Trial design
Design model
Parallel
Treatments tested in this trial
TENS
DeviceTENS will be performed from the moment of admission to the PCI, during the PCI and for the next 30 minutes after it.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Active TENSActive comparator 1 intervention
Group B: Sham TENSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Hospital mortality
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.2
30-day mortality
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 outcomes
1
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).
Time frame
From the date of randomization to the date of any of the listed events, assessed up to 14 days.Other outcomes
1
Assessment of the level of myocardial damage.
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.2
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.
Time frame
Diagnosis will be carried out during hospitalization and after 24 hours.3
Assessment of the level of heart failure
Dynamics of NT-proBNP in blood plasma.
Time frame
Diagnosis will be carried out during hospitalization and on the 4th day of hospitalization.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Bakulev Scientific Center of Cardiovascular Surgery
Lead sponsor
State Budget Public Health Institution Scientific Research Institute - Ochapovsky Regional Clinical Hospital
Collaborator
Source ClinicalTrials.gov