Diagnosing Pulmonary Embolism in the Context of Common Alternative Diagnoses in primary care

Completed

• Conditions: bloodclot in pulmonary artery; Pulmonary embolism; 10014523

• Registration Number: NL-OMON52757
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 750

Inclusion Criteria

- Subacute new onset or worsening of existing shortness of breath with or
without chest symptoms, in whom the general practitioner first wants to exclude
pulmonary embolism (PE);
- Age >= 18 years.

Exclusion Criteria

- Pregnancy;
- Already using anticoagulants (i.e. a vitamin K antagonist, low-molecular
weight heparine or a direct oral anticoagulant);
- Life expectancy < 1 month.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcomes of this study will be both the proportion false negatives<br /><br>(i.e. the proportion of missed PE cases with a negative YEARS-strategy) and the<br /><br>efficiency of the strategy (i.e. the total number of patients with a negative<br /><br>YEARS-strategy as a proportion of all suspected cases) in primary care. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints are the alternative diagnosis besides PE after 3 months<br /><br>of follow-up, with most importantly pneumonia. With this endpoint and the<br /><br>information obtained from the POC-assay for CRP, we will quantify the<br /><br>diagnostic value of CRP by multivariable logistic regression analyses. Besides,<br /><br>factors associated with a positive score on the subjective YEARS-item *PE most<br /><br>likely* will be identified.</p><br>