Follow-up of Kryptogenic Stroke Patients With Implantable vs. Non-invasive Devices to Detect Atrial Fibrillation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 主要终点
- To determine the prevalence of undiagnosed AF in stroke patients undergoing the diagnostic standard (24h-ECG)
研究概览
简要总结
Prospective mono-center diagnostic study determining potential discrepancies in identifying atrial fibrillation by intraindividually comparing different types of follow-up strategies:
- How many stroke patients with atrial fibrillation are missed by standard stroke unit 24h- electrocardiography, and
- what is the effectiveness of the extended invasive and non-invasive ECG analysis tools to detect atrial fibrillation in stroke patients?
详细描述
Atrial fibrillation often is paroxysmal and asymptomatic and, therefore, often not detected. Because atrial fibrillation is the leading risk factor for ischemic stroke, and oral anticoagulation is very efficacious for both primary and secondary stroke prevention in atrial fibrillation patients, detection of atrial fibrillation is essential to prevent stroke and stroke-induced disability and death. The incidence of atrial fibrillation and paroxysmal atrial fibrillation is particularly high in stroke patients. Short duration monitoring identified new atrial fibrillation in only about 5% to 10% of stroke patients. Estimates of missed paroxysmal atrial fibrillation in stroke patients go up to 40 000 patients in Germany per year.
Due to the known poor sensitivity of a 24h-ECG, all patients with stroke of unknown cause will undergo the above mentioned non-invasive and invasive ECG monitoring. Based on the data of these extended ECG-analyses, the rate of missed AF in conventionally diagnosed stroke unit patients could be determined by comparison to the 24h-ECG results. Additionally, a cost-benefit equation of the different ECG analysis tools will be calculated by comparison of the respective detection rates and the known follow-up costs.
Inclusion criteria: Patients years with acute ischemic stroke of unknown cause, monitored on a stroke unit undergoing routine diagnostic procedures (conventional 12-lead-ECG, 24h-ECG, echocardiography, cranial computed tomography or cranial magnetic resonance tomography, Transcranial Doppler and carotid duplex ultrasound, long-term blood pressure monitoring, standard laboratory investigations) Exclusion criteria: Stroke with known etiology, Stroke caused by intracranial hemorrhage
Diagnosis-as-usual:
- Standard 24h-ECG on stroke units according to existing guidelines
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
- 否
入选标准
- •Patients years with acute ischemic stroke of unknown cause, monitored on a stroke unit undergoing routine diagnostic procedures (conventional 12-lead-ECG, 24h-ECG, echocardiography, cCT or cMRI, Transcranial Doppler and carotid duplex ultrasound, long-term blood pressure monitoring, standard laboratory investigations)
排除标准
- •Stroke with known etiology, Stroke caused by intracranial hemorrhage
结局指标
主要结局
To determine the prevalence of undiagnosed AF in stroke patients undergoing the diagnostic standard (24h-ECG)
时间窗: 7.5 months
Based on the obtained data, the prevalence (in percent) of undiagnosed AF in stroke patients whom AF is missed by the standard diagnostic procedure (24h-ECG) will be determined by different extensive non-invasive and invasive ECG monitoring tools
次要结局
- Diagnostic accuracy of the automated software based ECG analysis in comparison to the "gold-standard" the implanted cardiac monitor(7.5 months)
