Integration of Pre-test PRObability, Focused Cardiac UltrasouNd and D-dimer for Diagnosis of acUte Aortic Syndromes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,023
- 试验地点
- 12
- 主要终点
- Failure rate of integrated diagnostic strategies for rule-out of acute aortic syndromes
研究概览
简要总结
Observational, prospective, multicentre, international, non-profit, investigator-driven, outcome and diagnostic accuracy study performed in Emergency Departments. The study will evaluate the performance of diagnostic algorithms integrating pre-test probability assessment with a risk score, focus cardiac ultrasound and D-dimer, to rule-in/out acute aortic syndromes. For each patient, the outcome will be established after review of hospital and 30-day follow-up data.
In participating centers, an acute aortic syndrome will be considered to be ruled out without advanced imaging by a D-dimer level lower than 500 ng per milliliter, in patients with a low clinical pre-test probability assessed using the aortic dissection detection (ADD) risk score. Using outcome data, the study will primarily assess the accuracy and efficiency of this diagnostic rule-out protocol (prospective management study). The study will also evaluate the performance of alternative rule out strategies based on a different clinical score and on a D-dimer cutoff adjusted on patient's age.
详细描述
Background and rationale. Acute aortic syndromes (AASs) are deadly and difficult to diagnose cardiovascular emergencies. AASs include acute aortic dissection, intramural aortic hematoma, penetrating aortic ulcer and spontaneous aortic rupture. A conclusive diagnosis of AASs requires an advanced imaging exam, such as computed tomographic angiography (CTA), transoesophageal echocardiography (TEE) or magnetic resonance imaging. These exams are time-consuming, costly and frequently require transfer of patients to specialized clinical centres. CTA, the most frequently used advanced imaging exam for suspected AASs in the Emergency Department (ED), exposes patients to significant ionizing radiations and to contrast medium, carrying inherent risks of anaphylaxis and contrast nephropathy. Selection of patients necessitating an advanced aortic imaging exam is therefore worrisome. There is a need for standardized diagnostic management of AAS workup, and in particular for a validated diagnostic algorithm incorporating evidence-based decision rules allowing:
- rapid identification of patients necessitating urgent CTA;
- safe rule-out of patients not requiring CTA. Based on available guidelines and further evidence, standardized decision rules for rule-in and rule-out of AASs can effectively based on integration of: (1) standardized pre-test probability assessment, (2) bedside imaging of the aorta with focus cardiac ultrasound (FoCUS), and (3) biomarker testing (D-dimer assay).
Aim of the study. The aim of the present study is to evaluate the performance of integrated diagnostic algorithms for standardized diagnostic workup (rule-in/out) of AASs. Primary outcome will be the occurrence of AASs in patients at low clinical pre-test probability presenting a negative D-dimer test result.
Setting. The study will be performed in several international EDs. Participating EDs will satisfy the following criteria for 24 hours / 7 days, in their routine clinical practice: (1) experienced use of bedside FoCUS, (2) local access to urgent D-dimer (DD) assay, (3) local access to urgent CTA. Both hub and spoke centers will be allowed to participate in the study, if local census is >30.000 visits/years.
Study design. This will be an observational, prospective, multicentre, international, non-profit, investigator-driven, outcome and diagnostic accuracy study. The study protocol does not imply any modification in the routine diagnostic and therapeutic approach to patients with suspected AASs. The only difference from standard care will be:
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
- 否
入选标准
- •Presence of ≥1 of the following symptoms, dating ≤14 days: neck pain, truncal (thoracic/back/abdominal) pain, syncope, organ perfusion deficit (focal neurologic deficit, limb ischemia);
- •AAS considered as meaningful diagnostic concern based on clinical judgement of the attending physician.
排除标准
- •Age <18 years;
- •Evident alternative diagnoses to acute aortic syndromes (e.g. herpes zoster, skeletal pain);
- •Primary trauma;
- •History of previous acute aortic syndrome;
- •Patient's refusal to participate.
结局指标
主要结局
Failure rate of integrated diagnostic strategies for rule-out of acute aortic syndromes
时间窗: 1 mont after the end of recruitment
The failure rate (or false negative proportion) of each diagnostic strategy will be calculated as the number of patients with a final diagnosis of AAS divided by the number of patients satisfying rule-out criteria.
Diagnostic performance of integrated diagnostic strategies for acute aortic syndromes
时间窗: 1 mont after the end of recruitment
The diagnostic performance of each diagnostic strategy will be assessed by computing sensitivity, specificity, negative/positive predictive values and negative/positive likelihood ratios with their 95% confident interval (95% CI).
Efficiency of integrated diagnostic strategies for rule-out of acute aortic syndromes
时间窗: 1 mont after the end of recruitment
The rule-out efficiency of each diagnostic strategy will be calculated as the number of patients satisfying the rule-out criteria divided by the number of all included patients.
次要结局
- Efficiency of integrated diagnostic strategies for rule-in of acute aortic syndromes(1 month after the end of recruitment)
研究者
Peiman Nazerian
Vice Director Emergency Department
Azienda Ospedaliero-Universitaria Careggi