Aortic Dissection Detection Risk Score With D-dimer to Rule-Out Acute Aortic Syndrome
2026年8月3日 更新者：Colin Graham、Chinese University of Hong Kong
The Combination of Aortic Dissection Detection Risk Score With D-dimer to Rule-Out Acute Aortic Syndrome: Multicentre Prospective Study in Emergency Departments
The goal of this study is to evaluate the safety of integrating the Aortic Dissection Detection Risk Score (ADD-RS) and D-dimer testing for ruling out acute aortic syndrome (AAS) in the emergency department (ED).
The main question it aims to answer: Can the combination of the ADD-RS <2, and D dimer <500ng/mL rule-out AAS in ED patients without CTA?
The researchers will recruit patients suspected with AAS in the ED, and the patients will receive a ADD-RS score, a D-dimer testing after signing a written consent.
研究概览
研究类型
观察性的
注册 (估计的)
746
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Colin Graham, Professor
- 电话号码：+852 35051698
- 邮箱：cagraham@cuhk.edu.hk
研究联系人备份
- 姓名：Rebecca Li, Miss
- 电话号码：35051698
学习地点
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-
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Hong Kong、香港
- Accident and Emergency Department, Queen Mary Hospital
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接触：
- Rex Lam
- 电话号码：3917 9175
- 邮箱：lampkrex@hku.hk
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Shatin、香港
- Prince of Wales Hospital
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接触：
- Rebecca Li
- 电话号码：35051698
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
Patients presenting to the ED meeting the above criteria during the recruitment timeframe
描述
Inclusion Criteria:
- Adult patients aged ≥ 18 years; AND
- Presentation to the ED with any of the following symptoms: acute onset (<14 days) chest pain, abdominal pain, back pain, syncope, or signs of malperfusion (e.g. limb ischemia, neurological deficit); AND
- AAS is considered as a possible differential diagnosis by the treating physician. Enrolment in the study will be determined by the attending physician during initial medical consultation in the ED and prior to establishing a final diagnosis.
Exclusion Criteria:
- An alternative diagnosis to AAS established by the treating physician after the initial assessment; OR
- Trauma cases; OR
- Patients with a known diagnosis of AAS before the index ED visit (e.g. with a diagnostic imaging done before the ED visit or referral from other institutions for AAS); OR
- Clinical severity or other conditions not allowing complete evaluation/proper enrolment; OR
- Patient who refuse to participate.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
incidence of missed AAS within 30 days among patients identified as low risk (ADD-RS <2 and D-dimer <500 ng/mL) who did not undergo CTA
大体时间：From enrollment to 30 days after index visit
|
number of patients with ADD-RS <2 and a negative D-dimer who were actually AAS cases
|
From enrollment to 30 days after index visit
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
sensitivity of the proposed algorithm
大体时间：From enrolment to 30 days after the index visit
|
The sensitivity of using ADD-RS and D-dimer to rule out AAS without performing CTA in the ED
|
From enrolment to 30 days after the index visit
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
D-dimer levels in different subgroups
大体时间：After completion of recruitment, estimated 18 months
|
D-dimer levels will be compared across different subgroups of AAS, including aortic dissection ,intramural hematoma and penetrating aortic ulcer.
|
After completion of recruitment, estimated 18 months
|
|
Hospital length of stay
大体时间：From enrolment to 30 day follow-up
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The number of days for patients staying in the hospital
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From enrolment to 30 day follow-up
|
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proportion of patients undergoing CT imaging
大体时间：From enrolment til patient discharged from the ED, estimated within the day of enrolment
|
the percentage of patients underwent CT imaging in the ED
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From enrolment til patient discharged from the ED, estimated within the day of enrolment
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月13日
初级完成 (估计的)
2028年6月30日
研究完成 (估计的)
2028年12月31日
研究注册日期
首次提交
2026年6月4日
首先提交符合 QC 标准的
2026年6月8日
首次发布 (实际的)
2026年6月10日
研究记录更新
最后更新发布 (实际的)
2026年8月5日
上次提交的符合 QC 标准的更新
2026年8月3日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.