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Trial record 1 of 1 for:    NCT02086136
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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
Sponsor:
Information provided by (Responsible Party):
Peiman Nazerian, 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 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
Aortic Dissection

Study Type : Observational
Actual Enrollment : 1900 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort
Suspected AD
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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

Information from the National Library of Medicine

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


Locations
Brazil
Heart Institute, University of Sao Paolo
São Paulo, Brazil
Germany
Charitè Universitätsmedizin
Berlin, Germany
Italy
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
Pavia, Italy
Switzerland
Cardiovascular Research Institute (CRIB)
Basel, Switzerland
Sponsors and Collaborators
Azienda Ospedaliero-Universitaria Careggi
Investigators
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peiman Nazerian, Medical Doctor Emergency Medicine, Azienda Ospedaliero-Universitaria Careggi
ClinicalTrials.gov Identifier: NCT02086136     History of Changes
Other Study ID Numbers: 1000
First Posted: March 13, 2014    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Keywords provided by Peiman Nazerian, Azienda Ospedaliero-Universitaria Careggi:
aortic dissection
diagnosis
emergency medicine
d-dimer

Additional relevant MeSH terms:
Fibrin fragment D
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants