Transcutaneous Vagal Nerve Stimulation to Prevent Tachyarrhythmias in Patients Early Following Myocardial Infarction: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 7
- 主要终点
- Change of Ventricular tachycardia burden
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Change of Ventricular tachycardia burden
时间窗: 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).
次要结局
- Change of Left Ventricle Ejection Fraction (LVEF)(1, 7 and 40 days follow-up)
- Change of Signal Averaged ECG(1, 7 and 40 days follow-up)
- Change of Heart Rate Variability(1, 7 and 40 days follow-up)
- Change of T Wave alternans and equal indexes derived from holter monitoring(1, 7 and 40 days follow-up)
- Change of QT duration(1, 7 and 40 days follow-up)
- Pain assessment(7 days follow-up)
- Change of Heart Rate Turbulence(1, 7 and 40 days follow-up)
- Change of Echocardiographic strain(1, 7 and 40 days follow-up)
- Number of participants with adverse effects(7 days follow-up)
- Change of Deceleration Capacity (DC)(1, 7 and 40 days follow-up)
研究者
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
Hippocration General Hospital