Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05992259 |
Other study ID # |
#12 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.