Aortic Dissection Detection Risk Score Plus D-dimer in the Diagnostic Workup of Suspected Acute Aortic Dissection: a Prospective Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,900
- 试验地点
- 6
- 主要终点
- Accuracy of ADD risk score and d-dimer in suspected aortic dissection
研究概览
简要总结
Acute aortic dissection (AD) is a deadly, difficult to diagnose disease presenting with an array of common and unspecific symptoms. Aortic dissection detection (ADD) risk score is a bedside clinical tool to estimate the risk of AD. D-dimer has been evaluated in several studies as a biomarker of AD and has showed a pooled diagnostic sensitivity of 97%. However, considering the severe morbidity and mortality of AD, a negative d-dimer per se is considered insufficient to rule-out AD in unselected patients.
The aim of the present study is to evaluate whether the diagnostic performance of d-dimer differs in patients at different clinical risk of AD, and in particular whether a negative d-dimer test may allow safe rule-out of AD in any patient subgroup without necessity to perform urgent aortic imaging.
Consecutive adult patients with suspected AD presenting to Emergency Department will be enrolled before the establishment of a final diagnosis; a standardized clinical form comprehensive of presence/absence of 12 risk markers allowing ADD risk score fulfilled and d-dimer levels measured at presentation.
The aortic imaging exam used to confirm or refuse of AD will be computed tomography angiography or transesophageal echocardiography and final diagnosis established after reviewing of all available data.
The accuracy, failure rate and efficiency of a diagnostic strategy combining standardized clinical stratification via the ADD risk score with d-dimer testing will therefore be assessed.
详细描述
Acute AD will include the following etiological entities, also known as acute aortic syndromes: acute aortic dissection, intramural aortic hematoma, penetrating aortic ulcer and spontaneous aortic rupture.
A pre-specified secondary sub-analysis will evaluate the diagnostic accuracy of focus cardiac ultrasound (FoCUS) and chest x ray for suspected AD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >18 years
- •Presentation to the ED with any of the following symptoms: chest pain, back pain, abdominal pain, syncope or symptoms of perfusion deficit (central nervous system, mesenteric, myocardial, or limb ischemia)
- •Aortic dissection considered among the differential diagnosis by the attending physician. Enrollment in the study will be decided by the attending physician during evaluation in the ED and before the establishment of a final diagnosis.
排除标准
- •An alternative diagnosis to AD objectively established by the attending physician after the initial medical evaluation
- •Clinical severity or other conditions not allowing complete evaluation/proper enrollment
- •Lack of consent to participate to the study
结局指标
主要结局
Accuracy of ADD risk score and d-dimer in suspected aortic dissection
时间窗: 2 weeks after the end of recruitment
The diagnostic performance of d-dimer will be assessed by computing sensitivity, specificity, negative and positive predictive values and negative and positive likelihood ratios with their 95% confident interval (95% CI) in all patients and within ADD risk score classes. The ADD risk score will be calculated based on the number of categories where at least one risk marker is present. Patients will be divided in low-risk (0 risk markers, ADD risk score 0), intermediate-risk (ADD risk score 1, at least 1 risk marker in 1 ADD risk category) and high-risk (ADD risk \>1, at least 1 risk marker in \>1 ADD risk categories). For diagnostic accuracy analyses, also a category of non-high-risk patients (ADD risk score ≤1) will be used.
次要结局
- Efficiency and failure rate of a diagnostic strategy using ADD risk score and d-dimer(2 weeks after the end of recruitment)
研究者
Peiman Nazerian
Medical Doctor Emergency Medicine
Azienda Ospedaliero-Universitaria Careggi