Sposato Luciano A, Ayan Diana, Ahmed Mobeen, Fridman Sebastian, Mandzia Jennifer L, Elrayes Maged, Lodol Facundo, Khaw Alexander V, Mai Lauren M, Bogiatzi Chrysi, Casserly Courtney, Fraser J Alexander, Chan Richard, Florendo Cumbermack Anita, Markovic Nevena, Yu Yeyao, Debicki Derek, Fleming Lorraine, Beauchamp Beth, Lambourn Lindsay, Mayich Michael, Milroy Lindsay, Sharma Manas, Pandey Sachin, Bagur Rodrigo
Department of Clinical Neurological Sciences, London Health Sciences Centre, Schulich School of Medicine, Western University, London, Ontario, Canada; Brain & Heart Lab, Schulich School of Medicine, Western University, London, Ontario, Canada; Department of Epidemiology & Biostatistics, Schulich School of Medicine, Western University, London, Ontario, Canada; Department of Anatomy & Cell Biology, Schulich School of Medicine, Western University, London, Ontario, Canada; Robarts Research Institute, Schulich School of Medicine, Western University, London, Ontario, Canada; Stroke Research Unit, London Health Sciences Centre, Schulich School of Medicine, Western University, London, Ontario, Canada.
Brain & Heart Lab, Schulich School of Medicine, Western University, London, Ontario, Canada.
Lancet Neurol. 2025 Jun;24(6):489-499. doi: 10.1016/S1474-4422(25)00111-5.
Cardioembolic sources often remain undetected after standard diagnostic stroke workup, contributing to high rates of recurrence. We aimed to assess whether a head-to-neck CT angiography extended at least 6 cm below the carina (extended CT angiography) can increase the detection of cardioaortic thrombi compared with standard-of-care CT angiography (standard CT angiography) in patients with ischaemic stroke or transient ischaemic attack.
This single-centre, prospective, randomised, open-label, blinded end-point trial was done at London Health Sciences Centre, Western University, Canada. Eligible patients were adults aged 18 years or older with ischaemic stroke or transient ischaemic attack assessed during acute code strokes. Exclusion criteria were known allergy or concerns about the safety of iodinated contrast agents (eg, severe renal failure) and no intravenous access. Participants were randomly assigned in a 1:1 ratio to receive standard CT angiography or extended CT angiography. Patients, neurologists adjudicating qualifying events, cardiothoracic radiologists, and cardiologists adjudicating study outcomes were masked to randomisation. Adjudicators were considered masked to randomisation as they did not know which patients were crossovers, which patients in the standard of care arm had partial imaging of the left atrial appendage due to normal variations in size and shape, and which patients in the extended CT angiography group also had partial imaging of the left atrial appendage instead of full imaging. The primary efficacy outcome was the detection of a cardioaortic thrombus (modified intention-to-treat population). The primary safety outcome was time to CT angiography completion (as-treated population). The trial was registered at ClinicalTrials.gov, NCT05522244, and is closed.
Between July 17, 2023, and May 6, 2024, 963 patients were assessed for inclusion. 133 were excluded because they already had a CT angiography at their local hospital, intracranial haemorrhage was identified on the initial non-contrast CT, a diagnosis of stroke was considered highly unlikely by the treating stroke neurologist, or randomisation was not possible. 830 patients were enrolled and randomly assigned to extended CT angiography (n=415) or standard CT angiography (n=415). One patient withdrew consent and was excluded from the analyses. 364 participants who were later adjudicated as having experienced stroke mimics were excluded. 465 patients with ischaemic stroke or transient ischaemic attack were included in the modified intention-to-treat population (226 in the extended CT angiography group and 239 in the standard CT angiography group). 239 (51%) of 465 patients were female and 226 (49%) were male. Median age of the analysis group at enrolment was 78·0 years (IQR 69·0-84·0). The primary outcome (cardioaortic thrombus) was detected in 20 (8·8%) of 226 patients in the extended CT angiography group and four (1·7%) of 239 in the standard CT angiography group (odds ratio 5·70, 95% CI 1·92-16·96; p=0·002). There were no statistically significant differences in the median time from code stroke activation to CT angiography completion between the extended CT angiography group (21·0 min; IQR 15·8-27·0 min) and the standard CT angiography group (20·0 min, 17·0-26·0 min). The median difference between extended CT angiography and standard CT angiography groups was 1·0 min (-1·0 to 2·5), p=0·67).
Performing extended CT angiography during acute code strokes is feasible and results in increased cardioaortic thrombi detection without causing delays in CT angiography completion. Future studies should assess whether extended CT angiography can reduce recurrent stroke risk by prompting early anticoagulation after thrombus detection.
Western University, and the Kathleen and Dr Henry Barnett Chair in Stroke Research.
在标准的诊断性卒中检查后，心源性栓塞源常常仍未被发现，这导致了高复发率。我们旨在评估，对于缺血性卒中或短暂性脑缺血发作患者，与标准治疗CT血管造影（标准CT血管造影）相比，在隆突下方至少6厘米处进行的头颈部CT血管造影（扩展CT血管造影）是否能增加心主动脉血栓的检出率。
这项单中心、前瞻性、随机、开放标签、盲终点试验在加拿大西安大略大学伦敦健康科学中心进行。符合条件的患者为18岁及以上的成年人，在急性卒中编码期间被评估为患有缺血性卒中或短暂性脑缺血发作。排除标准为已知对碘化造影剂过敏或对其安全性存在担忧（如严重肾衰竭）以及无静脉通路。参与者按1:1比例随机分配接受标准CT血管造影或扩展CT血管造影。患者、判定合格事件的神经科医生、心胸放射科医生以及判定研究结果的心脏病专家对随机分组情况不知情。判定者被视为对随机分组不知情，因为他们不知道哪些患者是交叉组，标准治疗组中哪些患者因左心耳大小和形状的正常变异而对左心耳进行了部分成像，以及扩展CT血管造影组中哪些患者也对左心耳进行了部分成像而非完整成像。主要疗效结局是心主动脉血栓的检出（改良意向性治疗人群）。主要安全性结局是CT血管造影完成时间（实际治疗人群）。该试验已在ClinicalTrials.gov注册，注册号为NCT05522244，现已结束。
在2023年7月17日至2024年5月6日期间，对963名患者进行了纳入评估。133名患者被排除，原因是他们已在当地医院进行了CT血管造影、初始非增强CT发现颅内出血、治疗卒中的神经科医生认为卒中诊断极不可能或无法进行随机分组。纳入830名患者并随机分配至扩展CT血管造影组（n = 415）或标准CT血管造影组（n = 415）。1名患者撤回同意并被排除在分析之外。364名后来被判定为经历了卒中模拟发作的参与者被排除。465名缺血性卒中或短暂性脑缺血发作患者被纳入改良意向性治疗人群（扩展CT血管造影组226名，标准CT血管造影组239名）。465名患者中239名（51%）为女性，226名（49%）为男性。分析组入组时的中位年龄为78.0岁（IQR 69.0 - 84.0）。扩展CT血管造影组226名患者中有20名（8.8%）检测到主要结局（心主动脉血栓），标准CT血管造影组239名患者中有4名（1.7%）检测到（比值比5.70，95% CI 1.92 - 16.96；p = 0.002）。扩展CT血管造影组（21.0分钟；IQR 15.8 - 27.0分钟）与标准CT血管造影组（20.0分钟，17.0 - 26.0分钟）从卒中编码激活到CT血管造影完成的中位时间无统计学显著差异。扩展CT血管造影组与标准CT血管造影组的中位差值为1.0分钟（-1.0至2.5），p = 0.67）。
在急性卒中编码期间进行扩展CT血管造影是可行的，可增加心主动脉血栓的检出率，且不会导致CT血管造影完成延迟。未来研究应评估扩展CT血管造影能否通过在血栓检测后促使早期抗凝来降低复发性卒中风险。
西安大略大学，以及凯瑟琳和亨利·巴尼特博士卒中研究主席职位。
