ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 7 of 435 for:    Recruiting, Not yet recruiting, Available Studies | "Embolism and Thrombosis"

Influence of Diagnostic Errors on the Prognosis of Acute Pulmonary Embolism (IDEA-PE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03101384
Recruitment Status : Recruiting
First Posted : April 5, 2017
Last Update Posted : June 2, 2017
Sponsor:
Information provided by (Responsible Party):
Guy Meyer, European Georges Pompidou Hospital

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.

Condition or disease Intervention/treatment
Pulmonary Embolism Pulmonary Embolism and Thrombosis Diagnostic Errors Embolism Pulmonary Vascular Disorder Other: Diagnostic error

Study Type : Observational
Estimated Enrollment : 302 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influence of Diagnostic Errors on the Prognosis of Acute Pulmonary Embolism
Actual Study Start Date : April 11, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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)
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.

Patient without a diagnostic error
Any patient that did not meet the criteria to define the diagnostic error



Primary Outcome Measures :
  1. Severity of pulmonary embolism at the time of diagnosis [ Time Frame: Day 1 ]
    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


Secondary Outcome Measures :
  1. Complication of pulmonary embolism [ Time Frame: Day 30 and 180 ]
    Composite of death, shock and recurrence

  2. Frequency of diagnostic errors [ Time Frame: Day 1 ]
    Frequency of diagnostic errors

  3. Characteristic of patient with diagnosis errors [ Time Frame: Day 30 ]
    Characteristic of patient with diagnosis errors



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with an episode of first acute symptomatic pulmonary embolism
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03101384


Contacts
Contact: Guy Meyer, Pr 06 25 50 04 58 guy.meyer@aphp.fr
Contact: Benoit Côté, Md 06 25 50 04 58 benoit.cote.6@ulaval.ca

Locations
France
Hôpital européen Georges Pompidou Recruiting
Paris, Ile de France, France, 75015
Contact: Guy Meyer, Pr.       guy.meyer@aphp.fr   
Contact: Benoit Côté, Dr.    06 25 50 04 58    benoit.cote.6@ulaval.ca   
Sponsors and Collaborators
European Georges Pompidou Hospital
Investigators
Principal Investigator: Guy Meyer, Pr Hôpital Européen Georges Pompidou, AP-HP

Responsible Party: Guy Meyer, Professeur des Universités, European Georges Pompidou Hospital
ClinicalTrials.gov Identifier: NCT03101384     History of Changes
Other Study ID Numbers: N° ID RCB : 2017-A00433-50
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: June 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Thrombosis
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases