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临床试验/NCT04644679
NCT04644679终止不适用

48-hour Versus 7-day Monitoring for the Detection of Atrial Fibrillation in Patients with Cryptogenic Stroke

Hospital Italiano de Buenos Aires1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2020年11月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
49
试验地点
1
主要终点
Atrial fibrillation

研究概览

简要总结

Randomized clinical trial comparing two monitoring strategies, the use of a 48-hour Holter (routine care branch) and an event recorder for 7 days (intervention branch).

Patients admitted for cryptogenic stroke will be included. Enrollment and randomization of patients will be carried out during the index case hospitalization, while follow-up will be done on an outpatient basis until day 7.

详细描述

Once the diagnose of cryptogenic stroke have been carried out, informed consent will be taken and participants will be randomized to 48-hour monitoring arm or 7-day monitoring arm, followed by discharge from hospital.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
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

  • •All patients who have studies that classify stroke or TIA as cryptogenic and who can carry out monitoring for 48 hours or 7 days will be included.
  • •Age ≥ 18 years

排除标准

  • •History of atrial fibrillation (or atrial flutter) documented.
  • •Patients who already have an event recorder in place, permanent pacemaker, or implantable cardioverter-defibrillator
  • •Evidence of lacunar infarction.
  • •Hemorrhagic stroke
  • •Patient for palliative care

研究组 & 干预措施

48-hr

Active Comparator

48-hr electrocardiographic monitoring

干预措施: 48-hr electrocardiographic monitoring (Diagnostic Test)

7-day

Experimental

7-day electrocardiographic monitoring

干预措施: 7-day electrocardiographic monitoring (Diagnostic Test)

结局指标

主要结局

Atrial fibrillation

时间窗: 7 days

Detection of one episode of atrial fibrillation or atrial flutter \>30 seconds up to 7 days

次要结局

  • Supraventricular arrhythmia(7 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

EMILIANO ROSSI

MD

Hospital Italiano de Buenos Aires

研究点 (1)

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