ACTRN12621000863831招募中未知
Smart Wars II: Withings ScanWatch versus Implantable Loop Recorder for Diagnosing Atrial Fibrillation after Unexplained Stroke
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Diagnosis
入排标准
- 年龄范围
- 50 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Recent episode (<60 days) of cryptogenic symptomatic TIA or recent episode of ESUS.
- •A stroke/TIA is considered to be ESUS if no possible cause can be determined despite extensive workup according to the standard protocol of the participating centre.
- •The following tests are minimally required as standard tests to establish the diagnosis of cryptogenic stroke:
- •MRI or CT brain
- •12-lead ECG for AF detection
- •24-h ECG monitoring for AF detection and Holter
- •Transthoracic echocardiogram
- •CTA or MRA of head and neck to rule out other causes of stroke pathologies
- •2. Patient or legally authorized representative is willing to sign patient consent form
- •3. Patient is > 55 years old with at least one other vascular risk factor (Hypertension, Diabetes, Heart Failure, previous coronary artery or peripheral vascular disease, previous stroke and obesity)
排除标准
- •1. Patient has known aetiology of the TIA or stroke (based on neuro-/cardiac/vascular imaging), such as:
- •Angiographic signs of large-artery atherosclerosis (MRA, CTA, or digital subtraction angiography) in the artery feeding the acute ischemic territory
- •Radiographic appearance consistent with acute small-artery occlusion, with lesion b1 cm in diameter (DWI or CT).
- •Evidence of a high-risk cardiac or aortic arch source of embolism (LV or LA thrombus or smoke,” emboligenic valvular lesion or tumour, PFO with source of venous thromboembolism, aortic arch plaque N3 mm thick or with mobile components or any other high-risk lesion)
- •History of spontaneous DVT
- •Stroke of other determined cause such as presence of nonatherosclerotic vasculopathies, hypercoagulable states (must be tested in patients <55 years old) and haematological disorders
- •2.Patient has untreated hyperthyroidism.
- •3.Patients had myocardial infarction <1 month before stroke/TIA.
- •4.Patient had coronary bypass grafting <1 month before stroke/TIA.
- •5.Patient has valvular disease requiring immediate surgical intervention.
- •6.Patient has documented history of AF or atrial flutter.
- •7.Patient has presence of a PFO, and PFO is/was an indication to start OAC in the patient according to the ESO guidelines.
- •8.Patient has permanent indication for anticoagulation at enrolment.
- •9.Patient has permanent OAC contraindication.
- •10.Patient is already included in another clinical trial that will affect the objectives of this study.
- •11.Patient's life expectancy is <1 year.
- •12.Patient is pregnant.
- •13.Patient is indicated for implant with a pacemaker, ICD, CRT device, or an implantable hemodynamic monitoring system
- •14.Patient is not fit, or is unable or unwilling to follow the required procedures of the Clinical Investigation Plan.
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