Influence of Diagnostic Errors on the Prognosis of Acute Pulmonary Embolism
IDEA-PE
1 other identifier
observational
302
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2017
CompletedFirst Posted
Study publicly available on registry
April 5, 2017
CompletedStudy Start
First participant enrolled
April 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedJune 2, 2017
June 1, 2017
1.5 years
March 29, 2017
June 1, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Severity of pulmonary embolism at the time of diagnosis
According to the 2014 Europe Society of Cardiology classification that combine clinical characteristics, signs of right ventricular dysfunction on imaging test and cardiac laboratory biomarkers
Day 1
Secondary Outcomes (3)
Complication of pulmonary embolism
Day 30 and 180
Frequency of diagnostic errors
Day 1
Characteristic of patient with diagnosis errors
Day 30
Study Arms (2)
Patient with a diagnostic error
Defined by one of : 1. Absence of prescribed test included in an accepted pulmonary diagnosis algorithm in the next 48h00 after the firts contact with a physician 2. Absence of prescribed test included in an accepted pulmonary diagnosis algorithm by the first contacted physician but the diagnostic is done before 48h00 because the patient went at the emergency room on his own initiative. 3. More than one doctor consulted before the diagnostic of pulmonary embolism (excluding the emergency physician if the patient was referred by the 1st contact doctor)
Patient without a diagnostic error
Any patient that did not meet the criteria to define the diagnostic error
Interventions
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.
Eligibility Criteria
Patient with an episode of first acute symptomatic pulmonary embolism
You may qualify if:
- years and older
- Episode of symptomatic acute pulmonary embolism objectively proven
You may not qualify if:
- Below 18 years of age
- Patient chronically receiving therapeutic anticoagulation
- Pulmonary embolism complicating a current hospitalisation for another medical reason
- Asymptomatic pulmonary embolism
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hôpital européen Georges Pompidou
Paris, Île-de-France Region, 75015, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guy Meyer, Pr
Hôpital Européen Georges Pompidou, AP-HP
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professeur des Universités
Study Record Dates
First Submitted
March 29, 2017
First Posted
April 5, 2017
Study Start
April 11, 2017
Primary Completion
October 1, 2018
Study Completion
April 1, 2019
Last Updated
June 2, 2017
Record last verified: 2017-06