Diagnosis of Arrhythmias in Patients With Syncope by Continuous Cardiac Telemetry (Pocket-ECG III® System) or Conventional Holter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- length of time until diagnosis
研究概览
简要总结
The purpose of this study is to determine whether continuous cardiac telemetry with the Pocket-ECG III® system is more useful than conventional Holter to find out the cause of syncope
详细描述
Study population: adult patients with recurrent and/or with probable cardiac origin syncopes with indication of cardiac rhythm monitoring.
Estimated sample size: COLAPS trial showed that conventional 48-hours Holter and 4-weeks external loop recorder got a diagnosis in 22% and 56%, respectively, in patients with syncope. Based on this data, to compare two matched-proportions with α-risk=0.05 and β-risk=0.2, 34 patients would be needed; to compensate a 15-20% percentage of lost patients during follow-up, it is estimated that 40 patients is the number to include in the trial to demonstrate the effect.
Variables to collect:
Baseline variables: birthdate date (month, year), inclusion date, gender, number and features of syncopes, cardiovascular risk factors, electrocardiogram, type of cardiopathy, left ventricular ejection fraction, comorbidities and treatments.
Monitoring findings: diagnostic event and diagnostic fulfilled criteria, date of diagnostic event, date of last follow-up.
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
- Diagnostic
- 盲法
- Single (Investigator)
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
- •Patients with syncope refered to perform 24-hours conventional Holter who fulfill at least one of the following conditions:
- •≥2 episodes of syncope in the last year, provided that they are not typical vasovagal syncope, and/or
- •≥1 episode of syncope with any criterion of suspicion of cardiac-arrhythmic aetiology, according to current European Guidelines about management of syncope
排除标准
- •Carrier of any cardiac implantable electronic device or internal loop recorder, as well as stablished indication for it according to current guidelines.
- •Aetiologic diagnosis of syncope already known.
- •Left ventricular ejection fraction ≤35%.
- •Unability to perform the monitorization
研究组 & 干预措施
Pocket-ECG III System
After signing written informed consent, a Pocket-ECG III® system will be given to the patient. All participants will be monitored by the Pocket-ECG® system until a diagnosis is achieved or for a maximum of two months (whatever it happens first). Everyday daily reports sent via e-mail by the manufacturer company (MEDICALgorithmics© S.A.) will be reviewed by the investigator team; in case of a diagnosis event (according to prespecified diagnostic criteria from the European Society of Cardiology), appropriate treatment will be applied.
干预措施: Pocket-ECG III system (Device)
Conventional Holter
Every patient will be his/her own control. Conventional 24-hours Holter monitoring will be simulated using data obtained by the Pocket-ECG III® system in the first 24 hours, ignoring the registries of the rest of days. Two and Three 24-hours conventional Holter strategies will also be simulated analyzing data from first 24 hours and 1-2 additional days, respectively, chosen by means of a random number creation system which will identify the days of registry to be considered.
干预措施: Pocket-ECG III system (Device)
结局指标
主要结局
length of time until diagnosis
时间窗: two months
number of etiology diagnosis of syncope
时间窗: two months
Overall and per diagnosis costs
时间窗: Two months
次要结局
- length of properly analyzable registry(two months)
研究者
Ignacio Mosquera
MD, PhD
Complexo Hospitalario Universitario de A Coruña