ELectrophysiological Mechanisms Underlying the Inhibitory CArdiac Syncope: Therapeutic and Prognostic Implications The ELICA Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 主要终点
- syncope recurrence
研究概览
简要总结
OBJECTIVES: To evaluate syncope recurrence at follow up in patients with a positive cardio inhibitory response to the head up tilt testing (HUT) evaluation.
METHODS: 36 consecutive patients affected by cardio inhibitory syncope to HUT without asystolia (2A type) have been enrolled in this study. These patients have been studied by electrophysiological study (ES). After ES patients have been differently treated (interventional treatment group A, v/s drug therapy group), and followed up during 360 days, to evaluate syncope recurrences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •age more than 18, normal heart function, more than 1 syncope event for year.
排除标准
- •age inferior 18 years, history of myocardial infarction, heart failure, structural heart disease.
研究组 & 干预措施
electrophysiological testing
Patients will receive a pacemaker.
干预措施: pacemaker (Device)
control group
These subjects will receive cardicor® (beta blockers).
结局指标
主要结局
syncope recurrence
时间窗: 360 days
次要结局
未报告次要终点
研究者
Celestino Sardu
MD, MSc, PHD
University of Campania Luigi Vanvitelli