跳至主要内容
临床试验/NCT02893215
NCT02893215Unknown不适用

Silent Atrial Fibrillation - Screening of High-risk Groups for Atrial Fibrillation (The Silence Study)

Hvidovre University Hospital9 个研究点 分布在 3 个国家目标入组 1,622 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,622
试验地点
9
主要终点
Number of participants with silent atrial fibrillation as assessed by handheld ECG measurements in high-risk heart failure patients.

研究概览

简要总结

The primary aim of the present study is to screen high-risk type 2 diabetes patients and heart failure patients without any history of atrial fibrillation (AF), ongoing oral anticoagulation (OAC) treatment, implanted device or recent stroke/Transient Ischemic Attack (TIA), for silent AF.

Moreover, we aim to establish the prevalence of two or more risk factors for stroke in patients with heart failure and diabetes mellitus type 2 (DM2) with the aim of assessing the feasibility for this group to undergo AF screening.

Overall, the aim of the study is to prevent stroke in high-risk patients groups through identification of silent (asymptomatic) atrial fibrillation.

详细描述

The number of screened patients with respectively heart failure and type 2 diabetes with a risk score (Congestive Heart Failure, Hypertension, Aged 75 years or older, Diabetes, Stroke / transient cerebral ischemia, Vascular disease, Aged 65 years or older and Sex category (CHADSVASc)) of two or more, the number of these patients excluded due to AF or ongoing AF, the number of eligible patients not included for other reasons, and, finally, number of included patients will be listed.

Patients eligible for screening will be supplied with a hand-held ECG-recorder developed by Zenicor Medical Systems (www.zenicor.com) and will transmit recordings 4 times daily (morning, midday, evening -at meals - and before bedtime) and in case of symptoms, for 14 days.

The transmitted ECGs will be digitally stored, analyzed and screened for AF. All AF episodes will recorded and the day and time of the arrhythmia will be registered.

Eligible patients will be given brief oral and the more thorough written patient information about the study, and offered an appointment for the first meeting, which will happen in the Cardiological out-patient clinic in Copenhagen University Hospital (Hvidovre) with a member of the project group. During the first meeting, the patient will get more information about the study and has the possibility to ask questions. If the patient wants to bring a relative or friend already at this meeting, this can be arranged. If the patient meets the criteria and is interested in participation he/she will be invited to participation in the study. The patient gets the rest of the information material, i.e. written informed consent declaration, and is given a period for questioning and consideration of participation for at least three days. If the patient wants another visit for further information and possibly with participation of a relative or friend, such a visit is scheduled, and the patient can be included at this visit, and written informed consent declaration can be given to the project group member.

Heart failure patients will have a standardized echocardiography and diabetes patients will have supplementary registration of HbA1c, and latest blood glucose value. The latest level of creatinine and creatinine clearance will be registered for all patients (DM2 and congestive heart failure (CHF)).

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
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Systolic Congestive Heart Failure diagnosed by echocardiography showing a left ventricular ejection fraction (LVEF) ≤ 40%.
  • Diagnosed Diabetes Mellitus type II.
  • Age 65 years or older
  • CHADS-Vasc (Risk score) 2 or higher

排除标准

  • Previous history of AF
  • Ongoing OAC treatment
  • Implanted device
  • Recent stroke/TIA

结局指标

主要结局

Number of participants with silent atrial fibrillation as assessed by handheld ECG measurements in high-risk heart failure patients.

时间窗: 14 days

Number of participants with silent atrial fibrillation as assessed by handheld ECG measurements in high-risk type 2 diabetes patients.

时间窗: 14 days

次要结局

  • Number of participants with supraventricular ectopic activity.(14 days)
  • Number of participants with micro-atrial fibrillation.(14 days)
  • Number of participants with high risk of stroke in a heart failure population.(2 years)
  • Number of participants with high risk of stroke in a type 2 diabetes population.(2 years)

研究者

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

Valborg Heinesen

MD

Hvidovre University Hospital

研究点 (9)

Loading locations...

相似试验