Pulmonary EmbolismPERCEPICNCT02360540
PERCEPIC: PERC Rule Combined With Implicit Low Clinical Probability
An observational study of Pulmonary Embolism and Dyspnea, run by University Hospital, Angers at 12 sites in 2 countries.
Trial summary
PERC rule was created to rule out pulmonary embolism (PE) without further exams, with residual PE risk <2%. Its safety is currently confirmed in low PE prevalence populations as north-American. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism, Dyspnea, Thoracic Pain
- What is being tested?
- Gestalt estimation
- How many people
- 1,773 participants
- Where
- 12 sitesin 2 countries
- Study dates
- May 2015to Jul 2016
- How long will I take part?
- 3 Months
- 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: All patients admitted to the emergency department for dyspnea or thoracic pain without another obvious cause or suspected PE
Who may be able to join
- Patients admitted to the emergency department for one of the following criteria :
- Dyspnea and/or Thoracic pain without another obvious cause
- Pulmonary embolism suspicion whatever the reason
Who cannot join
- Age lower than 18
- Patients hospitalized for more than 48h
- Ongoing curative anticoagulant therapy for more than 48h before admission
- Patients with thromboembolic disease diagnosed before the admission
- Unavailability for follow-up (short life expectancy, no phone number…)
- Patient refusing to be contacted by phone at 3 month
- Patient refusing that medical data were collected
- Secondary exclusion criteria : curative anticoagulant therapy for more than 5 days during the 3 month follow-up for another reason than thromboembolic disease.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
France9 sites
Hospital of Agen
Agen
UH Angers
Angers
Hospital of Argenteuil
Argenteuil
UH Clermont-Ferrand
Clermont-Ferrand
Hospital of Le Mans
Le Mans
UH Nantes
Nantes
UH Poitiers
Poitiers
UH Rennes
Rennes
Hospital of Saint-Brieuc
Saint-Brieuc
Belgium3 sites
Clinique Universitaire Saint-Luc
Brussels
UH Erasme
Brussels
UH Liège
Liège
About this study
Official title: Performance of the Pulmonary Embolism Rule-out Criteria (the PERC Rule) Combined With Implicit Low Clinical Probability (Gestalt) to Rule-out PE Without Further Exams
PERC rule was created to rule out pulmonary embolism (PE) without further exams, with residual PE risk <2%. Its safety is currently confirmed in low PE prevalence populations as north-American. In European high PE prevalence population, it has been showed that PERC rule used alone or associated with low clinical probability assessed by revised Geneva score (RGS) was not safe. In retrospective study, we suggest that the combination of PERC rule with implicit clinical probability (gestalt) could allow the use of the PERC rule.
PERCEPIC, an observational prospective multicenter study performed in France and Belgium, will test this hypothesis. Therefore, 3000 patients will be included in 12 centers. Primary outcome will be the rate of thromboembolic events or death related or possibly related to PE in patients with low implicit clinical probability and negative PERC rule (8 criteria absents). Upper limit of confidence interval of this rate must be equal or lower than 3% to consider PERC rule as safe in this combination.
- Conditions
- Pulmonary Embolism, Dyspnea, Thoracic Pain
- Being tested
- Gestalt estimation
- Keywords
- Pulmonary Embolism, Diagnostic strategy, Exclusion, Clinical probability, Implicit Judgment (Gestalt), PERC
- Medical subject headings
- Pulmonary Embolism, Dyspnea, Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gestalt estimationOther
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the accuracy of the combination of low implicit clinical probability (gestalt) and negative PERC rule (8 criteria absents)
Rate of thromboembolic events or death related or possibly related to PE in patients with low implicit clinical probability and negative PERC rule. Upper limit of confidence interval of this rate must be equal or lower than 3% to consider PERC rule as safe in this combination
Measured: 3 months
Secondary outcomes (3)
To assess usefulness of PERC and implicit low clinical probability combination to reduce the use of further exams
Mean number of further exams performed per diagnostic strategy
Measured: During emergency managment
To assess the accuracy of PERC and low clinical probability combination depending of clinical probability assessment method (implicit assessment, revised Geneva Score, Wells Score and implicit overridden Geneva Score)
For each methods, AUC in receiver operating characteristic analyses of the 3-level classification scheme will be compared.
Measured: 3 months
To compare performances of clinical probability assessment methods : implicit assessment, revised Geneva Score, Wells Score and implicit overridden Geneva Score
For each methods, AUC in receiver operating characteristic analyses of the 3-level classification scheme will be compared
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 1,773 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Collaborators
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Responsible party
- Sponsor
- Investigators
- Pierre-Marie ROY, MD-PhD, Study chair, UH AngersAndréa PENALOZA, MD-PhD, Study director, Clinique Universitaire Saint-Luc, Bruxelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02360540
- Sponsor's protocol ID
- PHRC2014_02
- Acronym
- PERCEPIC
- Status last verified
- Sep 2016
- First submitted
- 5 Feb 2015
- Last updated
- 22 Sep 2016
- Results posted
- No
Publications
Penaloza A, Soulie C, Moumneh T, Delmez Q, Ghuysen A, El Kouri D, Brice C, Marjanovic NS, Bouget J, Moustafa F, Trinh-Duc A, Le Gall C, Imsaad L, Chretien JM, Gable B, Girard P, Sanchez O, Schmidt J, Le Gal G, Meyer G, Delvau N, Roy PM. Pulmonary embolism rule-out criteria (PERC) rule in European patients with low implicit clinical probability (PERCEPIC): a multicentre, prospective, observational study. Lancet Haematol. 2017 Dec;4(12):e615-e621. doi: 10.1016/S2352-3026(17)30210-7. Epub 2017 Nov 14.
PubMed 29150390
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of the Pulmonary Embolism Rule-out Criteria (the PERC Rule) Combined With Implicit Low Clinical Probability (Gestalt) to Rule-out PE Without Further Exams
- ClinicalTrials.gov ID
- NCT02360540
- Acronym / sponsor ID
- PERCEPIC / PHRC2014_02
- Conditions
- Pulmonary Embolism, Dyspnea, Thoracic Pain
- Keywords
- Pulmonary Embolism, Diagnostic strategy, Exclusion, Clinical probability, Implicit Judgment (Gestalt), PERC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,773 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Study start
- May 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 10 Feb 2015 (estimated)
- 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.
PERC rule was created to rule out pulmonary embolism (PE) without further exams, with residual PE risk <2%. Its safety is currently confirmed in low PE prevalence populations as north-American. In European high PE prevalence population, it has been showed that PERC rule used alone or associated with low clinical probability assessed by revised Geneva score (RGS) was not safe. In retrospective study, we suggest that the combination of PERC rule with implicit clinical probability (gestalt) could allow the use of the PERC rule.
PERCEPIC, an observational prospective multicenter study performed in France and Belgium, will test this hypothesis. Therefore, 3000 patients will be included in 12 centers. Primary outcome will be the rate of thromboembolic events or death related or possibly related to PE in patients with low implicit clinical probability and negative PERC rule (8 criteria absents). Upper limit of confidence interval of this rate must be equal or lower than 3% to consider PERC rule as safe in this combination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to the emergency department for dyspnea or thoracic pain without another obvious cause or suspected PE
Key inclusion criteria (3 listed)
- Patients admitted to the emergency department for one of the following criteria :
- Dyspnea and/or Thoracic pain without another obvious cause
- Pulmonary embolism suspicion whatever the reason
Key exclusion criteria (8 listed)
- Age lower than 18
- Patients hospitalized for more than 48h
- Ongoing curative anticoagulant therapy for more than 48h before admission
- Patients with thromboembolic disease diagnosed before the admission
- Unavailability for follow-up (short life expectancy, no phone number…)
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 |
|---|---|---|
| Gestalt estimation | Other | – |
Primary outcome
To assess the accuracy of the combination of low implicit clinical probability (gestalt) and negative PERC rule (8 criteria absents)
Time frame: 3 months
Rate of thromboembolic events or death related or possibly related to PE in patients with low implicit clinical probability and negative PERC rule. Upper limit of confidence interval of this rate must be equal or lower than 3% to consider PERC rule as safe in this combination
3 secondary outcomes
To assess usefulness of PERC and implicit low clinical probability combination to reduce the use of further exams
Time frame: During emergency managment
To assess the accuracy of PERC and low clinical probability combination depending of clinical probability assessment method (implicit assessment, revised Geneva Score, Wells Score and implicit overridden Geneva Score)
Time frame: 3 months
To compare performances of clinical probability assessment methods : implicit assessment, revised Geneva Score, Wells Score and implicit overridden Geneva Score
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2016.
- Derived from this study: PubMed 29150390Penaloza A, Soulie C, Moumneh T, Delmez Q, Ghuysen A, El Kouri D, Brice C, Marjanovic NS, Bouget J, Moustafa F, Trinh-Duc A, Le Gall C, Imsaad L, Chretien JM, Gable B, Girard P, Sanchez O, Schmidt J, Le Gal G, Meyer G, Delvau N, Roy PM. Pulmonary embolism rule-out criteria (PERC) rule in European patients with low implicit clinical probability (PERCEPIC): a multicentre, prospective, observational study. Lancet Haematol. 2017 Dec;4(12):e615-e621. doi: 10.1016/S2352-3026(17)30210-7. Epub 2017 Nov 14.
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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.
Pierre-Marie ROY, MD-PhD study chair
UH Angers
Andréa PENALOZA, MD-PhD study director
Clinique Universitaire Saint-Luc, Bruxelles
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism and Dyspnea, run by University Hospital, Angers at 12 sites in 2 countries.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France, Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the accuracy of the combination of low implicit clinical probability (gestalt) and negative PERC rule (8 criteria absents) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02360540, which also lists 1 linked publication.
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 22 Sep 2016.