EARLY-VAGUS: Transcutaneous Vagal Nerve Stimulation to Prevent Tachyarrhythmias in Patients Early Following Myocardial Infarction
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Active Transcutaneous Vagal Nerve Stimulation
|
Device: Parasym device (active, current (mA) < discomfort threshold)
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.
|
| Sham Comparator: Sham Transcutaneous Vagal Nerve Stimulation
|
Device: Parasym device (sham, current (mA) = 0)
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.
|
Outcome Measures
Primary Outcome Measures
- Change of Ventricular tachycardia burden [1, 7 and 40 days follow-up]
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).
Secondary Outcome Measures
- Change of Heart Rate Variability [1, 7 and 40 days follow-up]
Patients will undergo noninvasive continuous ECG monitoring using a 24-hour Holter monitoring at 1, 7 and 40 days to evaluate Heart Rate Variability
- Change of Heart Rate Turbulence [1, 7 and 40 days follow-up]
Patients will undergo noninvasive continuous ECG monitoring using a 24-hour Holter monitoring at 1, 7 and 40 days to evaluate Heart Rate Turbulence
- Change of Deceleration Capacity (DC) [1, 7 and 40 days follow-up]
Patients will undergo noninvasive continuous ECG monitoring using a 24-hour Holter monitoring at 1, 7 and 40 days to evaluate Deceleration Capacity
- Change of Echocardiographic strain [1, 7 and 40 days follow-up]
Patients will undergo echocardiography at 1, 7 and 40 days to assess Myocardial substrate lesions and Post-infraction fibrosis
- Change of Left Ventricle Ejection Fraction (LVEF) [1, 7 and 40 days follow-up]
Patients will undergo echocardiography at 1, 7 and 40 days to assess Left Ventricle Ejection Fraction
- Change of Signal Averaged ECG [1, 7 and 40 days follow-up]
Patients will undergo a 12-lead electrocardiogram at 1, 7 and 40 days
- Change of T Wave alternans and equal indexes derived from holter monitoring [1, 7 and 40 days follow-up]
Patients will undergo noninvasive continuous ECG monitoring using a 24-hour Holter monitoring at 1, 7 and 40 days
- Change of QT duration [1, 7 and 40 days follow-up]
Patients will undergo noninvasive continuous ECG monitoring using a 24-hour Holter monitoring at 1, 7 and 40 days
- Pain assessment [7 days follow-up]
Pain scores will be assessed on postoperative days 0-7 using the visual analog score (Scale 0-10). Zero for no pain and ten being the worst pain experienced. They will be obtained and recorded into the medical record by the nurse monitoring the subject as part of standard care
- Number of participants with adverse effects [7 days follow-up]
Number of participants with pruritus, flush, pain at the stimulation site
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female patients aged ≥18 years
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ST-elevation myocardial infarction which is treated with a primary percutaneous coronary intervention
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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:
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< 3 months after prior ablation
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Patients on amiodarone
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Patients with known thyroid issues, on renal-dialysis
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Life expectancy of < 12 months
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Complex congenital heart disease
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Cardiogenic shock
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Women who are pregnant (as evidenced by pregnancy test if pre-menopausal)
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Known channelopathy such as Brugada syndrome, long QT syndrome, or Catecholaminergic monomorphic ventricular tachycardia
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Symptomatic sinus bradycardia or sinus node dysfunction at baseline without an implantable pacemaker
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Complete heart block or trifascicular block without an implantable pacemaker
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Recurrent vasovagal syncope
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Pre-existing implantable cardioverter-defibrillator (ICD)
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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))
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On the heart transplant list
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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)
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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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Heart Rhythm Institute, University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
| 2 | First Department of Cardiology, Hippocration General Hospital, National and Kapodistrian University of Athens | Athens | Attica | Greece | 11527 |
| 3 | Athens Heart Center Amarousion | Athens | Attiki | Greece | 15125 |
| 4 | Biomedical Engineering, Khalifa University of Science and Technology | Abu Dhabi | United Arab Emirates |
Sponsors and Collaborators
- Hippocration General Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EARLY-VAGUS