Prolonged Cardiac Patch Ambulatory Electrocardiogram Versus Conventional Holter Recording For Detection of Atrial Fibrillation After Cerebral Ischemic Event: A Comparative Analysis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- Detection of newly diagnosed AF or atrial flutter within 24 hours of monitoring with cardiac ECG patch compared to conventional Holter.
研究概览
简要总结
The aim of this study is to compare the diagnostic yield of water-resistant, wireless 7-day cardiac ECG patch versus conventional 24-hour Holter recording in detecting paroxysmal atrial fibrillation in patients admitted with acute ischemic stroke or transient ischemic attack of undetermined etiology after completion of a standard clinical stroke workup.
详细描述
This is a cohort study with a paired comparison between a cardiac ECG patch and conventional Holter system to detect atrial fibrillation in patients with acute ischemic stroke or transient ischemic attack of undetermined etiology. An estimated total of 320 adult patients will be enrolled in this study. Each eligible patient will receive simultaneously a conventional 24h Holter monitoring and a 7d cardiac ECG patch monitoring.
OBJECTIVES:
Primary objective:
To determine the diagnostic yield of a cardiac ECG patch compared to conventional Holter monitor for detecting occult paroxysmal atrial fibrillation (AF) within 24 hours in patients admitted with acute ischemic stroke or transient ischemic attack (TIA) of undetermined etiology after completion of a standard clinical stroke work-up.
Secondary objective(s):
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
- •Age ≥18 years.
- •Diagnosis of acute ischemic stroke or transient ischemic attack (TIA) (WHO definition) of undetermined etiology made by neurologist within 7 days after the index event. The event must be either:
- •an ischemic stroke confirmed by neuroimaging; or
- •a TIA, defined as involving a focal unilateral motor deficit, speech/language deficit or hemianopia, with symptom duration <24 hours (note: amaurosis fugax/ transient monocular blindness, pure sensory spells, isolated vertigo spells, etc. do not qualify for enrolment given the potential for misdiagnosis of such events).
- •No AF detected in baseline 12-lead ECG on admission.
- •The following diagnostic test have already been completed as part of clinical routine post-stroke/TIA:
- •Brain imaging with CT or MRI,
- •Transthoracic echocardiography to congenital heart disease and endocarditis.
- •Recurrent stroke/TIA is inclusionary as long as patient meets inclusion/
排除标准
- •for study enrolment.
- •Exclusion Criteria:
- •Stroke of unknown time of symptom onset.
- •Modified Rankin Scale ≥5 on index admission.
- •Previous documented history of primary intracerebral bleeding.
- •Previous documented history of AF or atrial flutter (a remote history of transient AF during perioperative period is not exclusionary).
- •Skin allergies, conditions, or sensitivities to cardiac patch.
- •Exclusively retinal stroke or retinal TIA event.
- •Pre-existing indication for anticoagulation (eg. History of mechanical heart valve replacement, deep vein thrombosis).
- •Pre-existing contraindication for permanent anticoagulation (eg. hypocoagulable state).
- •Echocardiographic findings of congenital heart disease and endocarditis.
- •Indicated for pacemaker, implantable cardiac defibrillator (ICD), CRT device, or an implantable hemodynamic monitoring system.
- •Intravenous drug users (IVDUs).
- •Life expectancy < 1 year for reasons other than stroke (eg. Metastatic cancer disease).
- •Concomitant participation in other clinical trials involving investigational medications.
结局指标
主要结局
Detection of newly diagnosed AF or atrial flutter within 24 hours of monitoring with cardiac ECG patch compared to conventional Holter.
时间窗: 24 hours
Detection of newly diagnosed AF or atrial flutter within 24 hours of monitoring with cardiac ECG patch compared to conventional Holter.
次要结局
- Detection of AF or atrial flutter within 7 days of monitoring.(7 days)
- Proportion of stroke patients anticoagulated during follow-up.(3 months)
- Health Outcomes.(1 year)
- Time to first detection of AF or atrial flutter.(7 days)
- Rate of stroke recurrent, major adverse bleeding events and detection of AF outside the study protocol.(1 year)
研究者
Diana Hui Ping Foo
Principal Investigator
Sarawak General Hospital