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

NCT02086136 | Completed

• 1 other identifier: 1000
• Study Type: observational
• Target: 1,900
• Locations: 4 countries
• Sites: 6

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.

Conditions

Aortic Dissection

Keywords

aortic dissection; diagnosis; emergency medicine; d-dimer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Efficiency and failure rate of a diagnostic strategy using ADD risk score and d-dimer

  2 weeks after the end of recruitment

Other Outcomes (1)

• Secondary analysis of focus cardiac echocardiography (FoCUS) for diagnosis of aortic dissection

  2 years after after the end of recruitment

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead

Study Sites (6)

Heart Institute, University of Sao Paolo

São Paulo, Brazil

Location

Charitè Universitätsmedizin

Berlin, Germany

Location

Emergency Department, A.O.U. Città della Salute e della Scienza di Torino, Ospedale Molinette

Turin, Piedmont, 10126, Italy

Location

Emergency Department Azienda Ospedaliera Universitaria Careggi

Florence, Tuscany, 50134, Italy

Location

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Location

Cardiovascular Research Institute (CRIB)

Basel, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 31220387 DERIVED

• 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.

  PMID: 29030346 DERIVED

MeSH Terms

Conditions

Aortic Dissection; Disease

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Acute Aortic Syndrome; Aortic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor Emergency Medicine

Study Record Dates

• First Submitted: March 11, 2014
• First Posted: March 13, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 3, 2019

Record last verified: 2019-01

Locations

BR (1); DE (1); CH (1); IT (3)