跳至主要内容
临床试验/NCT04302311
NCT04302311Unknown不适用

Early Diagnosis of Atrial Fibrillation in the Wait-Time Prior to Seeing a Cardiologist (CATCH-AF)

Victoria Cardiac Arrhythmia Trials2 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2018年12月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
73
试验地点
2
主要终点
Time to atrial fibrillation diagnosis compared between arms as analysed by Kaplan-Meier survival curves

研究概览

简要总结

A randomized patient-oriented trial to investigate whether continual symptomatic use of the Kardia Mobile monitoring device is a superior strategy for diagnosing Atrial Fibrillation (AF) in comparison to normal ambulatory monitoring with a 24-hour Holter monitor. Patients with referrals to an Electrophysiologist, symptoms of AF but no documentation of AF, and with at least one stroke risk factor based on the CHADS2 scoring system are randomized 1:1 to Kardia Mobile monitoring versus Holter monitoring alone.

详细描述

Wait-times from referral by a family practitioner to seeing a specialist have increased greatly over the past 10 years in Canada. The Fraser institute reports an 11 week wait-time in BC in 20161. Our experience is that this is representative of the wait-time to see a cardiologist at our institute.

Family doctors can diagnose some cases of atrial fibrillation (AF) with a pulse check and 12-lead electrocardiogram (ECG). However this is the minority of patients and most diagnoses are made on the basis of more prolonged ambulatory ECG recordings as part of the investigation of paroxysmal symptoms by a specialist2.

There is an increasing prevalence of AF3 and the consequences of late diagnosis can be dire. For example a 76 year old lady with treated hypertension and yet to be diagnosed paroxysmal AF has a risk of 6.7% per year of suffering stroke, TIA or systemic thromboembolus4. During the ~11 week wait for an appointment plus a further ~8 week wait for thorough diagnostic testing and further follow up she therefore has a 2.5% risk of having an event. If this is multiplied across the thousands of patients waiting for appointments across Canada over the course of a year it is evident that numerous thromboembolic complications could be prevented through reduction of the time to diagnosis.

Furthermore the first-line investigation for diagnosis of paroxysmal arrhythmia is usually an ambulatory ECG monitor (Holter/Event monitor)5,6. However, patients frequently do not have symptoms during the period of monitoring and the diagnostic yield is between 15% and 39%7-10.

Implantable loop recorders (ILRs) can provide accurate and thorough ECG monitoring continuously for up to 3 years. However, they are used late in the diagnostic process and are too expensive for widespread use for AF screening and so can only have a limited impact on overall time to diagnosis.

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

入选标准

  • Referral for episodic symptoms that may be due to arrhythmia (e.g. palpitations, dyspnea, or pre-syncope)
  • At least one risk factor from CHADS-65 CCS Algorithm

排除标准

  • Previous diagnosis of atrial fibrillation
  • Already anticoagulated for another diagnosis (e.g. metallic heart valve or pulmonary embolism)
  • Symptoms typical of non-arrhythmic cause (e.g. exertional chest pain)

研究组 & 干预措施

Standard of Care

Active Comparator

Holter monitoring

干预措施: Holter monitoring (Diagnostic Test)

Enhanced Monitoring

Active Comparator

Kardia/AliveCor monitoring with additional Holter monitoring as needed

干预措施: Holter monitoring (Diagnostic Test)

Enhanced Monitoring

Active Comparator

Kardia/AliveCor monitoring with additional Holter monitoring as needed

干预措施: Kardia/AliveCor monitoring (Diagnostic Test)

结局指标

主要结局

Time to atrial fibrillation diagnosis compared between arms as analysed by Kaplan-Meier survival curves

时间窗: 6 months

using the Log-rank test.

次要结局

未报告次要终点

研究者

发起方
Victoria Cardiac Arrhythmia Trials
申办方类型
Other
责任方
Sponsor

研究点 (2)

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