Sposato Luciano A, Ayan Diana, Ahmed Mobeen, Fridman Sebastian, Mandzia Jennifer L, Lodol Facundo F, Elrayes Maged, Pandey Sachin, Bagur Rodrigo
Department of Clinical Neurological Sciences, Western University, London, Ontario, Canada.
Heart and Brain Laboratory, Western University, London, Ontario, Canada.
Cerebrovasc Dis. 2025;54(3):415-424. doi: 10.1159/000540034. Epub 2024 Jun 26.
Cardiac imaging is one of the main components of the etiological investigation of ischemic strokes. However, basic and advanced cardiac imaging remain underused in most stroke centers globally. Computed tomography angiography (CTA) of the supra-aortic and intracranial arteries is the most frequent imaging modality applied during the evaluation of patients with acute ischemic stroke to identify the presence of a large vessel occlusion. Recent evidence from retrospective observational studies has shown a high detection of cardiac thrombi, ranging from 6.6 to 17.4%, by extending a CTA a few cm below the carina to capture cardiac images. However, this approach has never been prospectively compared against usual care in a randomized controlled trial. The Extended Computed Tomography Angiography for the Successful Screening of Cardioaortic Thrombus in Acute Ischemic Stroke and TIA (DAYLIGHT) prospective, randomized, controlled trial evaluates whether an extended CTA (eCTA) + standard-of-care stroke workup results in higher detection rates of cardiac and aortic source of embolism compared to standard-of-care CTA (sCTA) + standard-of-care stroke workup.
DAYLIGHT is a single-center, prospective, randomized, open-blinded endpoint trial, aiming to recruit 830 patients with suspected acute ischemic stroke or transient ischemic attack (TIA) being assessed under acute code stroke at the emergency department or at a dedicated urgent stroke prevention clinic. Patients are randomized 1:1 to eCTA versus sCTA. The eCTA expands image acquisition caudally, 6 cm below the carina. All patients receive standard-of-care cardiac imaging and diagnostic stroke workup. The primary efficacy endpoint is the diagnosis of a cardioaortic thrombus after at least 30 days of follow-up. The primary safety endpoint is door-to-CTA completion time. The diagnosis of a qualifying ischemic stroke or TIA is independently adjudicated by a stroke neurologist, blinded to the study arm allocation. Patients without an adjudicated ischemic stroke or TIA are excluded from the analysis. The primary outcome events are adjudicated by a board-certified radiologist with subspecialty training in cardiothoracic radiology and a cardiologist with formal training in cardiac imaging. The primary analysis is performed according to the modified intention-to-diagnose principle and without adjustment by logistic regression models. Results are presented with odds ratios and 95% confidence intervals.
The DAYLIGHT trial will provide evidence on whether extending a CTA to include the heart results in an increased detection of cardioaortic thrombi compared to standard-of-care stroke workup.
心脏成像检查是缺血性卒中病因学调查的主要组成部分之一。然而,在全球大多数卒中中心,基础和高级心脏成像检查的应用仍然不足。在评估急性缺血性卒中患者以确定是否存在大血管闭塞时,主动脉弓和颅内动脉的计算机断层血管造影(CTA)是最常用的成像方式。近期回顾性观察研究的证据表明,通过将CTA扫描范围向下延伸至隆突以下几厘米以获取心脏图像,心脏血栓的检出率较高,为6.6%至17.4%。然而,在随机对照试验中,这种方法从未与常规治疗进行过前瞻性比较。急性缺血性卒中和短暂性脑缺血发作(TIA)的心脏主动脉血栓成功筛查扩展计算机断层血管造影(DAYLIGHT)前瞻性随机对照试验评估,与标准护理CTA(sCTA)+标准护理卒中检查相比,扩展CTA(eCTA)+标准护理卒中检查是否能提高心脏和主动脉栓塞源的检出率。
DAYLIGHT是一项单中心、前瞻性、随机、开放盲终点试验,旨在招募830例疑似急性缺血性卒中或短暂性脑缺血发作(TIA)的患者,这些患者在急诊科或专门的紧急卒中预防诊所接受急性卒中代码评估。患者按1:1随机分为eCTA组和sCTA组。eCTA将图像采集范围向下扩展至隆突以下6厘米。所有患者均接受标准护理心脏成像检查和诊断性卒中检查。主要疗效终点是随访至少30天后诊断为心脏主动脉血栓。主要安全终点是从就诊到完成CTA检查的时间。由对研究组分配不知情的卒中神经科医生独立判定是否符合缺血性卒中或TIA的诊断。未判定为缺血性卒中或TIA的患者被排除在分析之外。主要结局事件由一名具有心胸放射学亚专业培训的董事会认证放射科医生和一名具有心脏成像正式培训的心脏病专家判定。主要分析根据改良的意向性诊断原则进行,不通过逻辑回归模型进行调整。结果以比值比和95%置信区间表示。
DAYLIGHT试验将提供证据,证明与标准护理卒中检查相比,将CTA扩展至包括心脏是否能提高心脏主动脉血栓的检出率。