Aortic Dissection Detection Risk Score Plus D-dimer in Suspected Acute Aortic Dissection (ADVISED)
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|ClinicalTrials.gov Identifier: NCT02086136|
Recruitment Status : Completed
First Posted : March 13, 2014
Last Update Posted : January 23, 2018
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 as 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 ED 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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||1900 participants|
|Official Title:||Aortic Dissection Detection Risk Score Plus D-dimer in the Diagnostic Workup of Suspected Acute Aortic Dissection: a Prospective Multicenter Study|
|Study Start Date :||September 2014|
|Primary Completion Date :||December 2016|
|Study Completion Date :||December 2016|
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.
- Accuracy of ADD risk score and d-dimer in suspected aortic dissection [ Time Frame: 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 in patients with different ADD risk score. 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.
- Efficiency and failure rate of a diagnostic strategy using ADD score and d-dimer [ Time Frame: 2 weeks after the end of recruitment ]More than conventional accuracy measures even failure rate and the efficiency of D-dimer will be also calculated in high-risk patients (ADD 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 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02086136
|Heart Institute, University of Sao Paolo|
|São Paulo, Brazil|
|Emergency Department, A.O.Città della Salute e della Scienza di Torino, Ospedale Molinette|
|Torino, Piemonte, Italy, 10126|
|Emergency Department Azienda Ospedaliera Universitaria Careggi|
|Firenze, Tuscany, Italy, 50134|
|Fondazione IRCCS Policlinico San Matteo|
|Cardiovascular Research Institute (CRIB)|
|Principal Investigator:||Peiman Nazerian, MD||Emergency Departmen AOU Careggi|
|Principal Investigator:||Fulvio Morello, MD, PhD||A.O. Città della Salute e della Scienza, Molinette Hospital, Torino, Italy.|