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临床试验/NCT02725944
NCT02725944已完成不适用

Prediction and Detection of Occult Atrial Fibrillation in Patients After Acute Cryptogenic Stroke and Transient Ischemic Attack

University Hospital, Akershus1 个研究点 分布在 1 个国家目标入组 251 人开始时间: 2016年5月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
251
试验地点
1
主要终点
Detection of paroxysmal atrial fibrillation

研究概览

简要总结

PROACTIA is a prospective, event-driven observational study. It aims to propose a composite scoring system in order to evaluate the risk of paroxysmal atrial fibrillation (PAF) in patients after acute cryptogenic stroke and transient ischemic attack (TIA).

详细描述

It will be enrolled 250 participants of both sexes within two weeks after diagnosed cryptogenic stroke and/or TIA at Akershus University Hospital, Oslo area, Norway.

Evaluation of participants' comorbidity with CHADS2-VASc score, ECG, Holter ECG, echocardiography, detection of biochemical cardiac markers and screening for obstructive sleep apnea syndrome will be performed. All participants will be monitored with a continuous cardiac rhythm during one year by implantation of implantable cardiac rhythm monitors (ICRM). All patients without high bleeding risk will get prescribed oral anticoagulants (OAC) after detection of PAF.

A biobank will be established in order to store the sampled biological material.

研究设计

研究类型
Observational
观察模型
Cohort
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

入选标准

  • Patients diagnosed with cryptogenic stroke and/or TIA, in accordance to the TOAST (Trial of Org 10172 in Acute Stroke Treatment) classification.

排除标准

  • Patients with known or newly detected AF on initial examination including 24 h Holter ECG.
  • Patients on oral anticoagulants (OAC) for non-AF indications.
  • Patients with strong contraindications for OAC, even if the presence of underlying AF is detected.
  • Patients with atrial- or ventricular thrombi, or atheromas of the aortic arch greater than 4 mm, detected by transesophageal echocardiography.
  • Patients unable to sign the informed consent or with a life expectancy due to comorbidities of less than two years.

结局指标

主要结局

Detection of paroxysmal atrial fibrillation

时间窗: One year

次要结局

未报告次要终点

研究者

发起方
University Hospital, Akershus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Loreta Skrebelyte-Strøm, MD

MD

University Hospital, Akershus

研究点 (1)

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