Aortic Dissection Detection Risk Score Plus D-dimer in Suspected Acute Aortic Dissection
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/17/2017 |
| Start Date: | September 2014 |
| End Date: | December 2016 |
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 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.
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.
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
We found this trial at
2
sites
Click here to add this to my saved trials
Click here to add this to my saved trials