Clinical trial NCT02086136: Aortic Dissection Detection Risk Score Plus D-dimer in Suspected Acute Aortic Dissection
Official title: Aortic Dissection Detection Risk Score Plus D-dimer in the Diagnostic Workup of Suspected Acute Aortic Dissection: a Prospective Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Dissection
Keywords: aortic dissection
diagnosis
emergency medicine
d-dimer
Lead sponsor: Azienda Ospedaliero-Universitaria Careggi
Sponsor class: OTHER
First posted: 2014-03-13
Enrollment: 1900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive adult patients with suspected AD presenting to Emergency Departments will be enrolled at the time of initial medical evaluation and before the establishment of a final diagnosis

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.

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy of ADD risk score and d-dimer in suspected aortic dissection
timeFrame: 2 weeks after the end of recruitment
Secondary outcomes:
measure: Efficiency and failure rate of a diagnostic strategy using ADD risk score and d-dimer
timeFrame: 2 weeks after the end of recruitment
Other outcomes:
measure: Secondary analysis of focus cardiac echocardiography (FoCUS) for diagnosis of aortic dissection
timeFrame: 2 years after after the end of recruitment
Locations:
city: São Paulo
country: Brazil
facility: Heart Institute, University of Sao Paolo
city: Berlin
country: Germany
facility: Charitè Universitätsmedizin
city: Torino
country: Italy
facility: Emergency Department, A.O.U. Città della Salute e della Scienza di Torino, Ospedale Molinette
state: Piemonte
city: Firenze
country: Italy
facility: Emergency Department Azienda Ospedaliera Universitaria Careggi
state: Tuscany
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Basel
country: Switzerland
facility: Cardiovascular Research Institute (CRIB)
Study officials:
affiliation: Emergency Departmen AOU Careggi
name: Peiman Nazerian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: A.O. Città della Salute e della Scienza, Molinette Hospital, Torino, Italy.
name: Fulvio Morello, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nazerian P, Pivetta E, Veglia S, Cavigli E, Mueller C, de Matos Soeiro A, Leidel BA, Lupia E, Rutigliano C, Wussler D, Grifoni S, Morello F; ADvISED Investigators. Integrated Use of Conventional Chest Radiography Cannot Rule Out Acute Aortic Syndromes in Emergency Department Patients at Low Clinical Probability. Acad Emerg Med. 2019 Nov;26(11):1255-1265. doi: 10.1111/acem.13819. Epub 2019 Jul 22.
citation: Nazerian P, Mueller C, Soeiro AM, Leidel BA, Salvadeo SAT, Giachino F, Vanni S, Grimm K, Oliveira MT Jr, Pivetta E, Lupia E, Grifoni S, Morello F; ADvISED Investigators. Diagnostic Accuracy of the Aortic Dissection Detection Risk Score Plus D-Dimer for Acute Aortic Syndromes: The ADvISED Prospective Multicenter Study. Circulation. 2018 Jan 16;137(3):250-258. doi: 10.1161/CIRCULATIONAHA.117.029457. Epub 2017 Oct 13.