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

NCT ID: NCT05750108

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2024-12-31

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).

Conditions

Myocardial Infarction; Tachyarrhythmia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Active Transcutaneous Vagal Nerve Stimulation

Group Type: ACTIVE_COMPARATOR

Parasym device (active, current (mA) < discomfort threshold)

Intervention Type: DEVICE

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 Transcutaneous Vagal Nerve Stimulation

Group Type: SHAM_COMPARATOR

Parasym device (sham, current (mA) = 0)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hippocration General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Konstantinos Tsioufis

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Heart Rhythm Institute, University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

First Department of Cardiology, Hippocration General Hospital, National and Kapodistrian University of Athens

Athens, Attica, Greece

Athens Heart Center Amarousion

Athens, Attica, Greece

Biomedical Engineering, Khalifa University of Science and Technology

Abu Dhabi, , United Arab Emirates

Countries

United States; Greece; United Arab Emirates

Central Contacts

Konstantinos Tsioufis, Professor

Role: CONTACT

ktsioufis@hippocratio.gr

2132088000

Facility Contacts

Stavros Stavrakis, MD, PhD

Role: primary

Stavros-stavrakis@ouhsc.edu

Konstantinos Tsioufis, Professor

Role: primary

ktsioufis@hippocratio.gr

2132088000

Dimitrios Tsiachris, MD

Role: primary

dtsiachris@yahoo.com

Leontios Hadjileontiadis

Role: primary

leontios.hadjileontiadis@ku.ac.ae

Other Identifiers

EARLY-VAGUS

Identifier Type: -

Identifier Source: org_study_id