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

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Myocardial Infarction, Tachyarrhythmia

In brief

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).

Key facts

Study ID

NCT05750108

Run by

Hippocration General Hospital

People needed

40

Starts

2023-06-01

Expected to finish

2024-12-01

Last updated by the study team

2023-03-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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)

Where it is running

• 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

Full record on ClinicalTrials.gov

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