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

Aortic Dissection Clinical Trial

— ADvISED  

Official title:

Aortic Dissection Detection Risk Score Plus D-dimer in the Diagnostic Workup of Suspected Acute Aortic Dissection: a Prospective Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02086136
• Other study ID #: 1000
• Status: Completed
• Start date: September 2014
• Est. completion date: December 2016

Study information

• Verified date: January 2019
• Source: Azienda Ospedaliero-Universitaria Careggi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1900
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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

Related Conditions & MeSH terms

• Aortic Dissection

Locations

Country	Name	City	State
Brazil	Heart Institute, University of Sao Paolo	São Paulo
Germany	Charitè Universitätsmedizin	Berlin
Italy	Emergency Department Azienda Ospedaliera Universitaria Careggi	Firenze	Tuscany
Italy	Fondazione IRCCS Policlinico San Matteo	Pavia
Italy	Emergency Department, A.O.U. Città della Salute e della Scienza di Torino, Ospedale Molinette	Torino	Piemonte
Switzerland	Cardiovascular Research Institute (CRIB)	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Careggi

Countries where clinical trial is conducted

Brazil,  Germany,  Italy,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Secondary analysis of focus cardiac echocardiography (FoCUS) for diagnosis of aortic dissection	FoCUS will be performed during the Emergency Department index visit, before conclusive diagnosis. FoCUS will assess presence/absence of the following sonographic signs: intimal flap, intramural aortic hematoma, penetrating aortic ulcer, thoracic aorta enlargement, pericardial effusion/tamponade, aortic valve regurgitation. Conventional accuracy measures of FoCUS for aortic dissection will be assessed. Also the failure rate and efficiency of diagnostic strategies integrating FoCUS with ADD risk score and d-dimer test result will be assessed.	2 years after after the end of recruitment
Primary	Accuracy of ADD risk score and d-dimer in suspected aortic dissection	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.	2 weeks after the end of recruitment
Secondary	Efficiency and failure rate of a diagnostic strategy using ADD risk score and d-dimer	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.	2 weeks after the end of recruitment