Pulmonary Embolism Clinical Trial
Official title:
Ultrasound Wells Score vs Traditional Wells Score in the Diagnostic Approach to Pulmonary Embolism
Verified date | February 2016 |
Source | Azienda Ospedaliero-Universitaria Careggi |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Observational |
Pulmonary embolism (PE) should be suspected in patients with dyspnea, chest pain, syncope,
shock/hypotension, or cardiac arrest. Discriminating patients in different categories of
pre-test probability of PE has become a key step in all diagnostic algorithms for PE. The
most frequently used clinical prediction rule is the Wells score ("PE likely" > 4 points and
"PE unlikely" ≤ 4 points). PE can be safely ruled out in patients with a "PE unlikely"
associated with a negative d-dimer test result. Conversely, patients with "PE likely" or
positive d-dimer level should undergo further diagnostic testing, like multidetector
computed tomography pulmonary angiography (MCTPA).
Wells score accuracy is not optimal. Vein and lung US can be rapidly performed at bedside as
an extension of physical examination and have a high specificity. The aim of this study is
to evaluate if the combination of clinical data reported in the Wells score and US data
obtained from vein and lung US (US Wells score) has a better diagnostic accuracy compared to
traditional Wells score.
In adult patients suspected of PE traditional Wells score will be calculated and vein and
lung US (multiorgan US) will be performed in all patients and and US Wells score calculated.
The US Wells score differs from the traditional Wells score in the following items: "signs
and symptoms of DVT", replaced by "vein US showing DVT", and "alternative diagnosis less
likely than PE" replaced by "alternative diagnosis less likely than PE after multiorgan US".
This latter item is considered positive if at least one subpleural infarct is detected at
lung US, and negative if no subpleural infarcts are detected and an alternative diagnosis
like pneumonia, pleural effusion or diffuse interstitial syndrome may explain the symptoms
of presentation. If no findings are detected at lung US, the points for the item remain the
same assigned by traditional Wells score. Final diagnosis of PE will be preferentially
established by MCTPA and in patients discharged without a second level imaging test because
of negative Wells or d-dimer, and patients with not conclusive second level diagnostic test,
will enter the 3 months follow-up protocol.
The diagnostic performance of traditional and US Wells scores will be assessed by
calculating sensitivity, specificity, positive, and negative predictive value, and
likelihood ratios. Failure rate and efficacy of d-dimer in patients stratified as "PE
likely" and "PE unlikely" will also be calculated.
Status | Completed |
Enrollment | 444 |
Est. completion date | July 2015 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients more than 18 years old - Patients presenting with dyspnea, thoracic pain or syncope, palpitations, cardiac arrest - Suspicion of PE Exclusion Criteria: - Patient did not consent to participate in the study - Presence of a diagnosis alternative to PE objectively demonstrated after the first assessment. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliera Universitaria Careggi | Firenze | |
Italy | Ospedale San Paolo, Università degli studi di Milano | Milano | |
Italy | Department of Internal Medicine, Università degli studi di Perugia | Perugia | |
Italy | Azienda Ospedaliera Universitaria San Luigi Gonzaga | Torino |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliero-Universitaria Careggi |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ultrasound Wells score vs traditional Wells score diagnostic performance. | The diagnostic performance of traditional and US Wells scores will be assessed by calculating sensitivity, specificity, positive predictive value, negative predictive value, and likelihood ratios. | 2 weeks after the end of recruitment | No |
Secondary | Failure rate and efficiency of traditional and US Wells | Failure rate and efficacy of d-dimer in patients stratified as "PE likely" and "PE unlikely" will also be calculated. Failure rate (false negative proportion) will be calculated as the number of patients with negative d-dimer and confirmed PE diagnosis, divided for all patients with negative d-dimer in the same risk group. The efficiency will be calculated as the number of patients with negative d-dimer in one risk group divided for all patients included in the study. | 2 weeks after the end of recruitment | No |
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