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Pulmonary EmbolismNCT02190110

Pulmonary Embolism Diagnosis: Ultrasound Wells Score vs Traditional Wells Score

An observational study of Pulmonary Embolism, run by Azienda Ospedaliero-Universitaria Careggi at 4 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Pulmonary Embolism
How many people
444 participants
Where
4 sitesItaly
Study dates
Aug 2014to Jul 2015
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: Adult patients (more than 18 years old) suspected of PE presenting to ED will be recruited at the time of the medical evaluation and before a final diagnosis is established.

Who may be able to join

  • Patients more than 18 years old
  • Patients presenting with dyspnea, thoracic pain or syncope, palpitations, cardiac arrest
  • Suspicion of PE

Who cannot join

  • Patient did not consent to participate in the study
  • Presence of a diagnosis alternative to PE objectively demonstrated after the first assessment.

Trial locations and contacts

4 sites in 1 country.

Italy4 sites
  • Azienda Ospedaliera Universitaria Careggi

    Florence

  • Ospedale San Paolo, Università degli studi di Milano

    Milan

  • Department of Internal Medicine, Università degli studi di Perugia

    Perugia

  • Azienda Ospedaliera Universitaria San Luigi Gonzaga

    Torino

Other trials in Italy

About this study

Official title: Ultrasound Wells Score vs Traditional Wells Score in the Diagnostic Approach to Pulmonary Embolism

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.

Read more

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.

Keywords
Pulmonary embolism, diagnosis, emergency medicine, ultrasonography
Medical subject headings
Pulmonary Embolism, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02190110
Study groupRoleWhat they receive
Suspected pulmonary embolism patientsAdult patients (more than 18 years old) suspected of PE will be recruited at the time of the medical evaluation and before a final diagnosis is established

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 weeks after the end of recruitment

Secondary outcomes (1)
  1. 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.

    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.

  1. First posted15 Jul 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionJul 2015
  4. Study completionJul 2015

Resources

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
444 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02190110
Sponsor's protocol ID
1001
Status last verified
Feb 2016
First submitted
12 Jul 2014
Last updated
9 Feb 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Embolism, run by Azienda Ospedaliero-Universitaria Careggi at 4 sites in Italy.

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 2 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 9 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Italy. 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?

ultrasound Wells score vs traditional Wells score diagnostic performance. (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?
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 9 Feb 2016.

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