Utilizing LifeMap To Investigate Malignant Arrhythmia Therapeutic Efficacy in Athletes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Restitution Markers as Determined by R2I2 and PERS
研究概览
简要总结
The goal of this observational study is to learn if two specific heart electrical signal patterns can help in detecting the risk of dangerous heart rhythms in athletes, and to see if exercise-based tests can be used instead of invasive hospital procedures to record this electrical signals.
The main questions it aims to answer are:
- Can special ECG action potential duration markers (R2I2 and PERS) identify athletes who are at higher risk of sudden heart rhythm problems.
- Can an exercise test give the same information as a non-invasive electrophysiology study.
Researchers will compare athletes who have an implanted heart device (ICD) with athletes who do not, to see if there are differences in these heart signals.
Participants will undergo:
- ECG recordings during rest and exercise.
- If they have an ICD or pacemaker, an ECG will be recorded during a non invasive stimulation.
- A continuous 24 hour ECG.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 and over.
- •Participates in regular physical activity for at least 3 hours or greater weekly.
- •Having Implantable cardioverter defibrillator insitu (cases).
- •Having a cardiac pacemaker (control).
- •Having no cardiac device (control).
- •Sufficient capacity and agreement to participate orally and signed written consent forms.
- •Understanding of written and spoken English language.
排除标准
- •Pregnancy, as detected by positive urine pregnancy test result.
- •Inability to comply with study protocols.
- •Any iatrogenic cardiac pathology (stents, CABG etc).
- •Unstable ventricular tachycardia (>30 seconds).
- •Any unstable malignant arrhythmia.
- •Fever or presence of a clinically diagnosed febrile illness
结局指标
主要结局
Change in Restitution Markers as Determined by R2I2 and PERS
时间窗: The primary outcome measure is assessment of changes in the regional restitution instability index and peak ECG restitution slope at various time points including, baseline, during 15-minute exercise and during 15-minute electrophysiology study.
次要结局
- Non-invasive exercise-based tests correlate with electrophysiology study.(The secondary outcome looks at how the Regional Restitution Instability Index (R2I2) and Peak ECG restitution slope (PERS) measurements during a 15-minute exercise compare with those taken during 15 minute Non-Invasive Programmed Stimulation (NIPS).)