Clinical trial NCT05750108: Transcutaneous Vagal Nerve Stimulation to Prevent Tachyarrhythmias in Patients Early Following Myocardial Infarction
Official title: Transcutaneous Vagal Nerve Stimulation to Prevent Tachyarrhythmias in Patients Early Following Myocardial Infarction: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myocardial Infarction
Tachyarrhythmia
Keywords: transcutaneous vagal nerve stimulation
Lead sponsor: Hippocration General Hospital
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Among patients early following ST-segment (ST) elevation myocardial infarction, transcutaneous vagus nerve stimulation is associated with a reduce of the burden of premature ventricular contractions in the first 40 days post-myocardial infarction (MI).

The above hypothesis will be tested with a randomized, prospective, parallel, single-blind clinical trial. The expected study duration is approximately 12 months from the time the first subject is enrolled (planned for June 2023) to the time of study's termination date (December 2024). Patient enrollment is planned to take place at two major centers in Greece. The researchers will obtain approval by the institutional review board (IRB).


Eligibility criteria: Inclusion Criteria:

* Male or female patients aged ≥18 years
* ST-elevation myocardial infarction which is treated with a primary percutaneous coronary intervention
* Signed written informed consent by the patient for participation in the study and agreement to comply with the medication and the follow-up schedule

Exclusion Criteria:

A patient will be excluded from the study if one or more of all the following criteria are present:

* \< 3 months after prior ablation
* Patients on amiodarone
* Patients with known thyroid issues, on renal-dialysis
* Life expectancy of \< 12 months
* Complex congenital heart disease
* Cardiogenic shock
* Women who are pregnant (as evidenced by pregnancy test if pre-menopausal)
* Known channelopathy such as Brugada syndrome, long QT syndrome, or Catecholaminergic monomorphic ventricular tachycardia
* Symptomatic sinus bradycardia or sinus node dysfunction at baseline without an implantable pacemaker
* Complete heart block or trifascicular block without an implantable pacemaker
* Recurrent vasovagal syncope
* Pre-existing implantable cardioverter-defibrillator (ICD)
* Secondary prevention indication for an ICD (i.e. sustained ventricular arrhythmias occurring more than 48 hours after qualifying myocardial infarction (patients with ventricular arrhythmias occurring ≤48 hours of myocardial infarction, or with non-sustained ventricular tachycardia at any time, are not excluded))
* On the heart transplant list
* Recurrent unstable angina despite revascularisation (defined as ongoing chest pain or ischemic symptoms at rest or with minimal exertion despite adequate treatment with anti-anginal medications)
* Congestive heart failure New York Heart Association class IV, defined as shortness of breath at rest, which is refractory to medical treatment (not responding to treatment)

Primary outcomes:
measure: Change of Ventricular tachycardia burden
timeFrame: 1, 7 and 40 days follow-up
Secondary outcomes:
measure: Change of Heart Rate Variability
timeFrame: 1, 7 and 40 days follow-up
measure: Change of Heart Rate Turbulence
timeFrame: 1, 7 and 40 days follow-up
measure: Change of Deceleration Capacity (DC)
timeFrame: 1, 7 and 40 days follow-up
measure: Change of Echocardiographic strain
timeFrame: 1, 7 and 40 days follow-up
measure: Change of Left Ventricle Ejection Fraction (LVEF)
timeFrame: 1, 7 and 40 days follow-up
measure: Change of Signal Averaged ECG
timeFrame: 1, 7 and 40 days follow-up
measure: Change of T Wave alternans and equal indexes derived from holter monitoring
timeFrame: 1, 7 and 40 days follow-up
measure: Change of QT duration
timeFrame: 1, 7 and 40 days follow-up
measure: Pain assessment
timeFrame: 7 days follow-up
measure: Number of participants with adverse effects
timeFrame: 7 days follow-up
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: Heart Rhythm Institute, University of Oklahoma Health Sciences Center
state: Oklahoma
city: Athens
country: Greece
facility: First Department of Cardiology, Hippocration General Hospital, National and Kapodistrian University of Athens
state: Attica
city: Athens
country: Greece
facility: Athens Heart Center Amarousion
state: Attiki
city: Abu Dhabi
country: United Arab Emirates
facility: Biomedical Engineering, Khalifa University of Science and Technology
Study officials:
References: