Transcutaneous Vagal Nerve Stimulation to Prevent Tachyarrhythmias in Patients Early Following Myocardial Infarction
EARLY-VAGUS
1 other identifier
interventional
40
3 countries
4
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2023
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2023
CompletedFirst Posted
Study publicly available on registry
March 1, 2023
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedMarch 1, 2023
February 1, 2023
1 year
January 30, 2023
February 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of Ventricular tachycardia burden
Patients will undergo noninvasive continuous ECG monitoring using a 24-hour Holter monitoring at 1, 7 and 40 days to evaluate their number of Premature ventricular contractions (PVCs) and number of Non-Sustain Ventricular Tachycardias (NSVT).
1, 7 and 40 days follow-up
Secondary Outcomes (10)
Change of Heart Rate Variability
1, 7 and 40 days follow-up
Change of Heart Rate Turbulence
1, 7 and 40 days follow-up
Change of Deceleration Capacity (DC)
1, 7 and 40 days follow-up
Change of Echocardiographic strain
1, 7 and 40 days follow-up
Change of Left Ventricle Ejection Fraction (LVEF)
1, 7 and 40 days follow-up
- +5 more secondary outcomes
Study Arms (2)
Active Transcutaneous Vagal Nerve Stimulation
ACTIVE COMPARATORSham Transcutaneous Vagal Nerve Stimulation
SHAM COMPARATORInterventions
Active transcutaneous Vagal Nerve Stimulation (tVNS) (Parasym device, Parasym Health, Inc, London, UK) will be performed with a clip attached to the ear at 20 hertz (Hz), 250 microseconds (ms) at a current just below discomfort threshold for 30 minutes twice a day, starting on post-MI day 0. Stimulation will continue until 7 days post-MI or discharge.
Parasym device will be attached to the ear twice a day, turned on but current set to 0 milliamp (mA), starting on post-MI day 0. Stimulation will continue until 7 days post-MI or discharge.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Heart Rhythm Institute, University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
First Department of Cardiology, Hippocration General Hospital, National and Kapodistrian University of Athens
Athens, Attica, 11527, Greece
Athens Heart Center Amarousion
Athens, Attica, 15125, Greece
Biomedical Engineering, Khalifa University of Science and Technology
Abu Dhabi, United Arab Emirates
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Senior cardiology expert. Prof. Konstantinos P. Tsioufis, MD, PhD, FESC, FACC, Professor of Cardiology, Director of 1st Department of Cardiology, Hippokratio Hospital, University of Athens
Study Record Dates
First Submitted
January 30, 2023
First Posted
March 1, 2023
Study Start
June 1, 2023
Primary Completion
June 1, 2024
Study Completion
December 1, 2024
Last Updated
March 1, 2023
Record last verified: 2023-02