Aortic DissectionADvISEDNCT02086136
Aortic Dissection Detection Risk Score Plus D-dimer in Suspected Acute Aortic Dissection
An observational study of Aortic Dissection, run by Azienda Ospedaliero-Universitaria Careggi at 6 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aortic Dissection
- How many people
- 1,900 participants
- Where
- 6 sitesin 4 countries
- Study dates
- Sep 2014to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Italy3 sites
Emergency Department Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, 50134
Fondazione IRCCS Policlinico San Matteo
Pavia
Emergency Department, A.O.U. Città della Salute e della Scienza di Torino, Ospedale Molinette
Turin, Piedmont, 10126
About this study
Official title: Aortic Dissection Detection Risk Score Plus D-dimer in the Diagnostic Workup of Suspected Acute Aortic Dissection: a Prospective Multicenter Study
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.
Read more
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.
Read the 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.
- Conditions
- Aortic Dissection
- Keywords
- aortic dissection, diagnosis, emergency medicine, d-dimer
- Medical subject headings
- Aortic Dissection, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 2 weeks after the end of recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aortic DissectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peiman Nazerian, Azienda Ospedaliero-Universitaria Careggi
- Investigators
- Peiman Nazerian, MD, Principal investigator, Emergency Departmen AOU CareggiFulvio Morello, MD, PhD, Principal investigator, A.O. Città della Salute e della Scienza, Molinette Hospital, Torino, Italy.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02086136
- Sponsor's protocol ID
- 1000
- Acronym
- ADvISED
- Status last verified
- Jan 2019
- First submitted
- 11 Mar 2014
- Last updated
- 3 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31220387Nazerian 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.
PubMed 29030346
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aortic Dissection Detection Risk Score Plus D-dimer in the Diagnostic Workup of Suspected Acute Aortic Dissection: a Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT02086136
- Acronym / sponsor ID
- ADvISED / 1000
- Conditions
- Aortic Dissection
- Keywords
- aortic dissection, diagnosis, emergency medicine, d-dimer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,900 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 13 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 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.
1 secondary outcome
Efficiency and failure rate of a diagnostic strategy using ADD risk score and d-dimer
Time frame: 2 weeks after the end of recruitment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
- Derived from this study: PubMed 31220387Nazerian 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.
- Derived from this study: PubMed 29030346Nazerian 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peiman Nazerian, MD principal investigator
Emergency Departmen AOU Careggi
Fulvio Morello, MD, PhD principal investigator
A.O. Città della Salute e della Scienza, Molinette Hospital, Torino, Italy.
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Dissection, run by Azienda Ospedaliero-Universitaria Careggi at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy, Brazil, Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of ADD risk score and d-dimer in suspected aortic dissection (time frame: 2 weeks after the end of recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02086136, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2019.