Pulmonary EmbolismIDEA-PENCT03101384
Influence of Diagnostic Errors on the Prognosis of Acute Pulmonary Embolism
An observational study of Pulmonary Embolism and Pulmonary Embolism and Thrombosis, run by European Georges Pompidou Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism, Pulmonary Embolism and Thrombosis, Diagnostic Errors
- What is being tested?
- Diagnostic error
- How many people
- 302 participants
- Where
- 1 siteFrance
- Study dates
- 11 Apr 2017to Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with an episode of first acute symptomatic pulmonary embolism
Who may be able to join
- 18 years and older
- Episode of symptomatic acute pulmonary embolism objectively proven
Who cannot join
- Below 18 years of age
- Patient chronically receiving therapeutic anticoagulation
- Pulmonary embolism complicating a current hospitalisation for another medical reason
- Asymptomatic pulmonary embolism
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital européen Georges Pompidou
Paris, Île-de-France Region, 75015
Guy Meyer, Pr., guy.meyer@aphp.fr
Benoit Côté, Dr., 06 25 50 04 58, benoit.cote.6@ulaval.ca
About this study
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.
- Conditions
- Pulmonary Embolism, Pulmonary Embolism and Thrombosis, Diagnostic Errors, Embolism, Pulmonary Vascular Disorder
- Being tested
- Diagnostic error
- Medical subject headings
- Pulmonary Embolism, Thrombosis, Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic errorOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Diagnostic error | |
| Patient without a diagnostic error | Any patient that did not meet the criteria to define the diagnostic error |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Secondary outcomes (3)
Complication of pulmonary embolism
Composite of death, shock and recurrence
Measured: Day 30 and 180
Frequency of diagnostic errors
Frequency of diagnostic errors
Measured: Day 1
Characteristic of patient with diagnosis errors
Characteristic of patient with diagnosis errors
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start11 Apr 2017
- Primary completionOct 2018 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 302 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Georges Pompidou Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guy Meyer, European Georges Pompidou Hospital
- Investigators
- Guy Meyer, Pr, Principal investigator, Hôpital Européen Georges Pompidou, AP-HP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101384
- Sponsor's protocol ID
- N° ID RCB : 2017-A00433-50
- Acronym
- IDEA-PE
- Status last verified
- Jun 2017
- First submitted
- 29 Mar 2017
- Last updated
- 2 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Diagnostic Errors on the Prognosis of Acute Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT03101384
- Acronym / sponsor ID
- IDEA-PE / N° ID RCB : 2017-A00433-50
- Conditions
- Pulmonary Embolism, Pulmonary Embolism and Thrombosis, Diagnostic Errors, Embolism, Pulmonary Vascular Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 302 participants (estimated)
- Lead sponsor
- European Georges Pompidou HospitalUniversity, hospital or other
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 5 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with a diagnostic error | – | Other: Diagnostic errorDefined 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with an episode of first acute symptomatic pulmonary embolism
Key inclusion criteria (2 listed)
- 18 years and older
- Episode of symptomatic acute pulmonary embolism objectively proven
Key exclusion criteria (4 listed)
- Below 18 years of age
- Patient chronically receiving therapeutic anticoagulation
- Pulmonary embolism complicating a current hospitalisation for another medical reason
- Asymptomatic pulmonary embolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic errorThere 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. | Other | Patient with a diagnostic error |
Primary outcome
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
3 secondary outcomes
Complication of pulmonary embolism
Time frame: Day 30 and 180
Frequency of diagnostic errors
Time frame: Day 1
Characteristic of patient with diagnosis errors
Time frame: Day 30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy Meyer, Pr principal investigator
Hôpital Européen Georges Pompidou, AP-HP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism and Pulmonary Embolism and Thrombosis, run by European Georges Pompidou Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guy Meyer, Pr (06 25 50 04 58, guy.meyer@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of pulmonary embolism at the time of diagnosis (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2017.