Registry of Aortic Diseases to Model Adverse Events and Progression (ROADMAP) in Uncomplicated Type B Aortic Dissection: Study Design and Rationale.
Registry of Aortic Diseases to Model Adverse Events and Progression (ROADMAP) in Uncomplicated Type B Aortic Dissection: Study Design and Rationale.
复制标题
主动脉疾病登记，以模拟无并发症的 B 型主动脉夹层的不良事件和进展 (ROADMAP)：研究设计和基本原理。
DOI：
10.1148/ryct.220039
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发表时间：
2022
期刊：
影响因子：
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通讯作者：
Gleason,Tho
中科院分区：
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作者：
Mastrodicasa,Domenico;Willemink,MartinJ;Turner,ValeryL;Hinostroza,Virginia;Codari,Marina;Hanneman,Kate;Ouzounian,Maral;OcazionezTrujillo,Daniel;Afifi,RanaO;Hedgire,Sandeep;Burris,NicholasS;Yang,Bo;Lacomis,JoanM;Gleason,Tho
目的描述多中心、多中心、多中心的研究设计和方法学方法， 回顾性研究，以外部验证临床和基于成像的 预测晚期不良事件风险的模型 材料和方法主动脉疾病登记研究，以模拟不良事件和进展 （ROADMAP）是北卡罗来纳州10个学术主动脉中心之间的合作 美国和欧洲。两个中心此前已开发， 验证了最近开发的风险预测模型。临床和 来自八个ROADMAP中心的成像数据将用于外部 验证。初次住院后存活的uTBAD患者 2001年1月1日至2013年12月31日，随访至 2020年，将进行回顾性研究。临床和影像学数据来自 将收集索引住院和所有随访就诊 并传送到协调中心进行分析。 基线和随访CT扫描将通过心血管检查进行评价。 结果主要终点是晚期不良事件的发生， 动脉瘤形成（≥6 cm），主动脉迅速扩张 （≥1 cm/y）、致死性或非致死性主动脉破裂、新发难治性疼痛， 无法控制的高血压和器官或肢体灌注不良。的 先前推导的多变量模型将通过以下方式进行外部验证： 使用考克斯比例风险回归模型。结论这项研究将显示是否最近的临床和成像为基础的风险 uTBAD患者的预测模型可以推广到更大的 这是向个体化风险迈出的重要一步 关键词：CT血管造影术，血管，主动脉，夹层， 结果分析，主动脉夹层，MRI，TEVAR© RSNA，2022另见Rajiah在本期的评论。
PurposeTo describe the design and methodological approach of a multicenter, retrospective study to externally validate a clinical and imaging-based model for predicting the risk of late adverse events in patients with initially uncomplicated type B aortic dissection (uTBAD).Materials and MethodsThe Registry of Aortic Diseases to Model Adverse Events and Progression (ROADMAP) is a collaboration between 10 academic aortic centers in North America and Europe. Two centers have previously developed and internally validated a recently developed risk prediction model. Clinical and imaging data from eight ROADMAP centers will be used for external validation. Patients with uTBAD who survived the initial hospitalization between January 1, 2001, and December 31, 2013, with follow-up until 2020, will be retrospectively identified. Clinical and imaging data from the index hospitalization and all follow-up encounters will be collected at each center and transferred to the coordinating center for analysis. Baseline and follow-up CT scans will be evaluated by cardiovascular imaging experts using a standardized technique.ResultsThe primary end point is the occurrence of late adverse events, defined as aneurysm formation (≥6 cm), rapid expansion of the aorta (≥1 cm/y), fatal or nonfatal aortic rupture, new refractory pain, uncontrollable hypertension, and organ or limb malperfusion. The previously derived multivariable model will be externally validated by using Cox proportional hazards regression modeling.ConclusionThis study will show whether a recent clinical and imaging-based risk prediction model for patients with uTBAD can be generalized to a larger population, which is an important step toward individualized risk stratification and therapy.Keywords:CT Angiography, Vascular, Aorta, Dissection, Outcomes Analysis, Aortic Dissection, MRI, TEVAR© RSNA, 2022See also the commentary by Rajiah in this issue.