A Multicenter, National, Investigator-initiated, Randomized, Parallel-group, Registerbased Superiority Study to Compare Extended ECG Monitoring Versus Standard ECG Monitoring of 1-2 Days in Elderly Patients With Ischemic Stroke or TIA.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 3,300
- 试验地点
- 3
- 主要终点
- Composite of stroke, death and intracerebral bleeding
研究概览
简要总结
Stroke is one of the leading causes behind death and permanent disability in adults. Atrial fibrillation (AF) is the most common clinical arrhythmia and its prevalence is steeply increasing with age. Atrial fibrillation is associated with a manifold increase in the risk for stroke.
It is considered important to investigate the heart rhythm in stroke survivors without previously known AF, because detection of AF will prompt a change in antithrombotic treatment with subsequent lowering of the risk of recurrent stroke.
There are so far very few studies on the prognostic impact of ECG investigations post stroke. Despite this knowledge gap, ECG investigation post stroke is given high priority in national and international guidelines.
Considerable clinical resources are currently invested in these ECG investigations without knowledge of its utility.
The investigators plan a nationwide, randomised, register-based study (RRCT) including patients aged at least 70 years receiving in-hospital care for stroke or TIA (Transient Ischemic Attack). Included patients will be randomised to standard investigation (1-2 days of ECG ) or extended ECG investigation (14 days of ECG performed at least twice). Patients diagnosed AF will be offered anticoagulation treatment. Long-term follow-up will be performed via swedish health care registers.
The result of this trial will have major impact on the ECG screening recommendations for patients who have had stroke, a large group of patients with dismal prognosis.
详细描述
Purpose and aims
The purpose of the trial is to study the prognostic impact of ECG investigation after stroke or TIA.
The aim is to investigate if extended ECG screening after stroke as compared to standard ECG screening reduces the occurrence of the primary composite endpoint of stroke, death and intracranial bleeding in patients with stroke or transient ischemic attack (TIA). Secondary aims include effects on major bleeding, myocardial infarction, pacemaker implantation, atrial fibrillation prevalence, oral anticoagulation (OAC) treatment and cost effectiveness.
Survey of the field Ischemic stroke is one of the leading causes of mortality worldwide, and a major cause behind permanent disability in adults. Atrial fibrillation (AF) is the most prevalent permanent clinically relevant arrhythmia with a steeply increasing incidence with advancing age. Atrial fibrillation is also one of the strongest risk factors for stroke. The increased stroke risk associated with AF can be markedly reduced by OAC treatment.
Unfortunately, AF is paroxysmal and asymptomatic in a significant proportion of patients, leading to lower detection rates and a similar proportion of stroke survivors with an untreated risk factor and higher risk of stroke recurrence. For this reason, it is widely recommended to make ECG recordings in patients suffering from stroke and TIA in order to detect previously undiagnosed AF.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 70 years
- •A diagnosis of ischemic stroke or TIA within 14 days from inclusion.
排除标准
- •Previously diagnosed atrial fibrillation
- •Contraindication to oral anticoagulant treatment according to Summary of Product Characteristics.
- •Indication for anticoagulant treatment other than atrial fibrillation, e.g. venous thromboembolism or mechanical heart valve prosthesis
- •Dual antiplatelet therapy not interchangeable to oral anticoagulation
- •Patients with pacemaker, implantable cardioverter defibrillator or implantable cardiac monitor.
- •Patients who, according to the investigator, will not be able to comply with the study protocol.
研究组 & 干预措施
Extended ECG investigation
Participants will undergo 0-48 hours of continuous ECG recording and at least two long-term continuous ambulatory ECG recordings with a duration of 14 days each.
干预措施: Extended ECG investigation (Diagnostic Test)
Standard of care
Participants will undergo 24-48 hours of continuous ECG recording.
结局指标
主要结局
Composite of stroke, death and intracerebral bleeding
时间窗: at least 36 months of follow-up (study event driven)
Stroke is defined as the occurence of International Classification of Diseases (ICD) 10 codes I63 in swedish health care registers. Intracranial bleeding is defined as the occurence of ICD 10 codes I61 in swedish health care registers. Mortality is defined as death reported by the swedish registers on cause of death.
次要结局
- Individual components of the primary endpoint(at least 36 months of follow-up (study event driven))
- Major bleeding(at least 36 months of follow-up (study event driven))
- Myocardial infarction(at least 36 months of follow-up (study event driven))
- Pacemaker implantation(at least 36 months of follow-up (study event driven))
- Anticoagulation treatment(at least 36 months of follow-up (study event driven))
- Atrial fibrillation prevalence(at least 36 months of follow-up (study event driven))
- Adherence to long-term ECG recording(at least 36 months of follow-up (study event driven))
- Incidence of other prognostic arrhythmia during long-term ECG recording.(at least 36 months of follow-up (study event driven))
研究者
Johan Engdahl
Associate Professor, Senior consultant
Karolinska Institutet