Influence of Diagnostic Errors on the Prognosis of Acute Pulmonary Embolism

Pulmonary Embolism Clinical Trial

— IDEA-PE  

Official title:

Influence of Diagnostic Errors on the Prognosis of Acute Pulmonary Embolism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03101384
• Other study ID #: N° ID RCB : 2017-A00433-50
• Status: Recruiting
• Phase: N/A
• First received: March 29, 2017
• Last updated: June 1, 2017
• Start date: April 11, 2017
• Est. completion date: April 2019

Study information

• Verified date: June 2017
• Source: European Georges Pompidou Hospital
• Contact: Guy Meyer, Pr
• Phone: 06 25 50 04 58
• Email: guy.meyer[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 302
• Est. completion date: April 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diagnostic Errors
• Embolism
• Embolism and Thrombosis
• Pulmonary Embolism
• Pulmonary Embolism and Thrombosis
• Pulmonary Vascular Disorder
• Thrombosis
• Vascular Diseases

Intervention

Other:
• Diagnostic 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.

Locations

Country	Name	City	State
France	Hôpital européen Georges Pompidou	Paris	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
European Georges Pompidou Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Complication of pulmonary embolism	Composite of death, shock and recurrence	Day 30 and 180
Secondary	Frequency of diagnostic errors	Frequency of diagnostic errors	Day 1
Secondary	Characteristic of patient with diagnosis errors	Characteristic of patient with diagnosis errors	Day 30