Transcutaneous Vagal Nerve Stimulation to Prevent Tachyarrhythmias in Patients Early Following Myocardial Infarction

Myocardial Infarction Clinical Trial

— EARLY-VAGUS  

Official title:

Transcutaneous Vagal Nerve Stimulation to Prevent Tachyarrhythmias in Patients Early Following Myocardial Infarction: A Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05750108
• Other study ID #: EARLY-VAGUS
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2023
• Est. completion date: December 2024

Study information

• Verified date: February 2023
• Source: Hippocration General Hospital
• Contact: Konstantinos Tsioufis, Professor
• Phone: 2132088000
• Email: ktsioufis[@]hippocratio.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Tachyarrhythmia
• Tachycardia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Greece	Athens Heart Center Amarousion	Athens	Attiki
Greece	First Department of Cardiology, Hippocration General Hospital, National and Kapodistrian University of Athens	Athens	Attica
United Arab Emirates	Biomedical Engineering, Khalifa University of Science and Technology	Abu Dhabi
United States	Heart Rhythm Institute, University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Hippocration General Hospital

Countries where clinical trial is conducted

United States,  Greece,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change of Heart Rate Variability	Patients will undergo noninvasive continuous ECG monitoring using a 24-hour Holter monitoring at 1, 7 and 40 days to evaluate Heart Rate Variability	1, 7 and 40 days follow-up
Secondary	Change of Heart Rate Turbulence	Patients will undergo noninvasive continuous ECG monitoring using a 24-hour Holter monitoring at 1, 7 and 40 days to evaluate Heart Rate Turbulence	1, 7 and 40 days follow-up
Secondary	Change of Deceleration Capacity (DC)	Patients will undergo noninvasive continuous ECG monitoring using a 24-hour Holter monitoring at 1, 7 and 40 days to evaluate Deceleration Capacity	1, 7 and 40 days follow-up
Secondary	Change of Echocardiographic strain	Patients will undergo echocardiography at 1, 7 and 40 days to assess Myocardial substrate lesions and Post-infraction fibrosis	1, 7 and 40 days follow-up
Secondary	Change of Left Ventricle Ejection Fraction (LVEF)	Patients will undergo echocardiography at 1, 7 and 40 days to assess Left Ventricle Ejection Fraction	1, 7 and 40 days follow-up
Secondary	Change of Signal Averaged ECG	Patients will undergo a 12-lead electrocardiogram at 1, 7 and 40 days	1, 7 and 40 days follow-up
Secondary	Change of T Wave alternans and equal indexes derived from holter monitoring	Patients will undergo noninvasive continuous ECG monitoring using a 24-hour Holter monitoring at 1, 7 and 40 days	1, 7 and 40 days follow-up
Secondary	Change of QT duration	Patients will undergo noninvasive continuous ECG monitoring using a 24-hour Holter monitoring at 1, 7 and 40 days	1, 7 and 40 days follow-up
Secondary	Pain assessment	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	7 days follow-up
Secondary	Number of participants with adverse effects	Number of participants with pruritus, flush, pain at the stimulation site	7 days follow-up