Aortic Dissection Detection Risk Score Plus D-dimer in Suspected Acute Aortic Dissection

Completed

• Conditions: Aortic Dissection

• Registration Number: NCT02086136
• Lead Sponsor: Azienda Ospedaliero-Universitaria Careggi

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2014-03-11
• Study First Submitted QC: 2014-03-11
• Study First Posted: 2014-03-13
• Study Start: 2014-09
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-01
• Last Update Posted: 2019-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1900

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of ADD risk score and d-dimer in suspected aortic dissection	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.

Secondary Outcome Measures

Name	Time	Method
Efficiency and failure rate of a diagnostic strategy using ADD risk score and d-dimer	2 weeks after the end of recruitment	Conventional accuracy measures, failure rate and the efficiency of d-dimer will be calculated in high-risk patients (ADD risk score \>1), in low-risk patients (ADD risk score 0) and in the intermediate and low-risk patients combined (non high-risk patients, ADD risk score ≤1). Failure rate (false negative proportion) will be calculated as the number of patients with a negative d-dimer and a final diagnosis of AD divided by all patients with negative d-dimer in the same risk group. The efficiency of the diagnostic strategy will be calculated as the number of patients with a negative d-dimer within a risk group divided by all included patients.

Trial Locations

Locations (6)

Cardiovascular Research Institute (CRIB); 🇨🇭 Basel, Switzerland

Emergency Department Azienda Ospedaliera Universitaria Careggi; 🇮🇹 Firenze, Tuscany, Italy

Heart Institute, University of Sao Paolo; 🇧🇷 São Paulo, Brazil

Emergency Department, A.O.U. Città della Salute e della Scienza di Torino, Ospedale Molinette; 🇮🇹 Torino, Piemonte, Italy

Fondazione IRCCS Policlinico San Matteo; 🇮🇹 Pavia, Italy

Charitè Universitätsmedizin; 🇩🇪 Berlin, Germany