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ClinicalTrials.gov ID

NCT05750108

Lead Sponsor

Hippocration General HospitalOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

40Estimated

Last Update Posted

Mar 1, 2023Actual

Start Date

Jun 2023Estimated

Primary Completion Date

Jun 2024Estimated

Completion Date

Dec 2024Estimated

Official Title

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

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).

• Myocardial Infarction
• Tachyarrhythmia

• Parasym device (active, current (mA) < discomfort threshold)
• Parasym device (sham, current (mA) = 0)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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 Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Hippocration General HospitalOTHER

dtsiachris@yahoo.com