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Influence of Diagnostic Errors on the Prognosis of Acute Pulmonary Embolism

Influence of Diagnostic Errors on the Prognosis of Acute Pulmonary Embolism

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03101384
Acronym
IDEA-PE
Enrollment
302
Registered
2017-04-05
Start date
2017-04-11
Completion date
2019-04-30
Last updated
2017-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnostic Errors, Embolism, Pulmonary Embolism, Pulmonary Embolism and Thrombosis, Pulmonary Vascular Disorder

Brief summary

Diagnostic errors have been reported frequently in patient with pulmonary embolism since symptoms are not specific. However, there is only scarce evidence that the delay associated with diagnostic errors may impact patient prognosis. The aim of this study is to determine the frequency of diagnostic errors and if they are associated with more severe pulmonary embolism in term of initial presentation and complications.

Interventions

OTHERDiagnostic error

There is no intervention in our study. Patient will be managed with usual care. We will divide patients in the 2 groups according to the presence of diagnostic error.

Sponsors

European Georges Pompidou Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 18 years and older * Episode of symptomatic acute pulmonary embolism objectively proven

Exclusion criteria

* Below 18 years of age * Patient chronically receiving therapeutic anticoagulation * Pulmonary embolism complicating a current hospitalisation for another medical reason * Asymptomatic pulmonary embolism

Design outcomes

Primary

MeasureTime frameDescription
Severity of pulmonary embolism at the time of diagnosisDay 1According to the 2014 Europe Society of Cardiology classification that combine clinical characteristics, signs of right ventricular dysfunction on imaging test and cardiac laboratory biomarkers

Secondary

MeasureTime frameDescription
Complication of pulmonary embolismDay 30 and 180Composite of death, shock and recurrence
Frequency of diagnostic errorsDay 1Frequency of diagnostic errors
Characteristic of patient with diagnosis errorsDay 30Characteristic of patient with diagnosis errors

Countries

France

Contacts

Primary ContactGuy Meyer, Pr
guy.meyer@aphp.fr06 25 50 04 58
Backup ContactBenoit Côté, Md
benoit.cote.6@ulaval.ca06 25 50 04 58

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026