Kim Sul Ki, Wing-Lun Edwina, Chandrasekhar Jaya, Puri Aniket, Burgess Sonya, Ford Thomas J, Kovacic Jason, Graham Robert M, Psaltis Peter J, Zaman Sarah
Department of Cardiology, Westmead Hospital, Sydney, NSW, Australia.
Department of Cardiology, Royal Darwin Hospital, Darwin, NT, Australia; Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia; Menzies School of Health Research, Darwin, NT, Australia.
Heart Lung Circ. 2022 Dec;31(12):1612-1618. doi: 10.1016/j.hlc.2022.08.018. Epub 2022 Sep 28.
Spontaneous coronary artery dissection (SCAD) is an under-recognised cause of acute coronary syndrome (ACS) with a strong female predominance. There are currently limited prospective studies and no randomised controlled trials that inform on SCAD's best clinical care. Little is also known about predictors of acute SCAD deterioration or recurrence. We describe the study design of a multi-centre prospective and historical cohort study recruiting patients with SCAD across 15-20 sites in Australia/New Zealand (NZ). The primary aim is to describe the clinical presentation, management and outcomes along with predictors of acute deterioration and recurrence in a large Australian/NZ SCAD cohort, with international data pooling.
Consented patients diagnosed with SCAD during a hospital admission for an ACS will be prospectively followed at 30 days then yearly, for up to 5 years. Each recruiting site will also retrospectively identify historical cases of SCAD from the proceeding 10 years, with a waiver of consent. For historical cases, data will be collected in a de-identified manner with date of last follow-up or death obtained from the medical records. All cases undergo core laboratory adjudication of coronary angiography and any accompanying imaging to confirm SCAD diagnosis. The primary endpoint will be occurrence of major adverse cardiovascular events; a composite of all-cause mortality, recurrent myocardial infarction (including SCAD recurrence), stroke/transient ischaemic attack, heart failure, cardiogenic shock, cardiac arrest/ventricular arrhythmia, heart transplantation and, repeat/unplanned revascularisation. Secondary endpoints will include each individual primary outcome as well as acute SCAD extension and quality of life/Seattle Angina Score in prospectively recruited participants. Endpoints will be assessed at the end of the hospital admission and at 30-days, 1 year, and median long-term follow-up.
Multicentre ethics approval has been granted from the Western Sydney Local Health District Human Research Ethics Committee (2021/ETH00040).
The analysed results will be published in peer-reviewed journals on completion of the historical data collection and then on completion of the prospective data collection.
The ANZ-SCAD registry has been prospectively registered with the Australia and New Zealand Clinical Trials Registry (ACTRN12621000824864).
自发性冠状动脉夹层（SCAD）是急性冠状动脉综合征（ACS）的一个未被充分认识的病因，女性占主导。目前关于SCAD最佳临床治疗的前瞻性研究有限，且没有随机对照试验。对于急性SCAD病情恶化或复发的预测因素也知之甚少。我们描述了一项多中心前瞻性和历史性队列研究的研究设计，该研究在澳大利亚/新西兰（NZ）的15 - 20个地点招募SCAD患者。主要目的是描述一个大型澳大利亚/NZ SCAD队列的临床表现、管理和结局，以及急性病情恶化和复发的预测因素，并进行国际数据汇总。
因ACS住院期间被诊断为SCAD的同意参与研究的患者将在30天时进行前瞻性随访，然后每年随访一次，最长随访5年。每个招募地点还将回顾性地从过去10年中识别SCAD的历史病例，无需患者同意。对于历史病例，将以去识别化的方式收集数据，并从病历中获取最后随访日期或死亡日期。所有病例均接受冠状动脉造影及任何相关影像的核心实验室判定，以确认SCAD诊断。主要终点将是主要不良心血管事件的发生；包括全因死亡率、复发性心肌梗死（包括SCAD复发）、中风/短暂性脑缺血发作、心力衰竭、心源性休克、心脏骤停/室性心律失常、心脏移植以及重复/非计划血管重建的综合指标。次要终点将包括每个单独的主要结局，以及前瞻性招募参与者中的急性SCAD扩展和生活质量/西雅图心绞痛评分。终点将在住院结束时以及30天、1年和中位长期随访时进行评估。
已获得西悉尼地方卫生区人类研究伦理委员会的多中心伦理批准（2021/ETH00040）。
分析结果将在完成历史数据收集后，然后在完成前瞻性数据收集后发表在同行评审期刊上。
ANZ - SCAD注册研究已在澳大利亚和新西兰临床试验注册中心（ACTRN12621000824864）进行前瞻性注册。
