Ignite Creation Date:
2024-05-06 @ 7:23 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05992259
Status:
RECRUITING
Last Update Posted:
2023-08-15
First Post:
2023-06-27
Brief Title:
Auricular Vagus Stimulation and STEMI
Sponsor:
Bakulev Scientific Center of Cardiovascular Surgery
Organization:
Bakulev Scientific Center of Cardiovascular Surgery
Study Overview
Official Title:
Auricular Vagus Stimulation and ST-Segment Elevation Myocardial Infarction
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 doi101016jjcin201704036 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None