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PERCEPIC: PERC Rule Combined With Implicit Low Clinical Probability (PERCEPIC)

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ClinicalTrials.gov Identifier: NCT02360540
Recruitment Status : Completed
First Posted : February 10, 2015
Last Update Posted : September 22, 2016
Sponsor:
Collaborator:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Information provided by (Responsible Party):
University Hospital, Angers

Brief 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. 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.


Condition or disease Intervention/treatment
Pulmonary Embolism Dyspnea Thoracic Pain Other: Gestalt estimation

Study Type : Observational [Patient Registry]
Actual Enrollment : 1773 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
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
Study Start Date : May 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. To assess usefulness of PERC and implicit low clinical probability combination to reduce the use of further exams [ Time Frame: During emergency managment ]
    Mean number of further exams performed per diagnostic strategy

  2. 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 ]
    For each methods, AUC in receiver operating characteristic analyses of the 3-level classification scheme will be compared.

  3. To compare performances of clinical probability assessment methods : implicit assessment, revised Geneva Score, Wells Score and implicit overridden Geneva Score [ Time Frame: 3 months ]
    For each methods, AUC in receiver operating characteristic analyses of the 3-level classification scheme will be compared



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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
All patients admitted to the emergency department for dyspnea or thoracic pain without another obvious cause or suspected PE
Criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

  • 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.

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): NCT02360540


Locations
Belgium
Clinique Universitaire Saint-Luc
Bruxelles, Belgium
UH Erasme
Bruxelles, Belgium
UH Liège
Liège, Belgium
France
Hospital of Agen
Agen, France
UH Angers
Angers, France
Hospital of Argenteuil
Argenteuil, France
UH Clermont-Ferrand
Clermont-Ferrand, France
Hospital of Le Mans
Le Mans, France
UH Nantes
Nantes, France
UH Poitiers
Poitiers, France
UH Rennes
Rennes, France
Hospital of Saint-Brieuc
Saint-Brieuc, France
Sponsors and Collaborators
University Hospital, Angers
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
Study Chair: Pierre-Marie ROY, MD-PhD UH Angers
Study Director: Andréa PENALOZA, MD-PhD Clinique Universitaire Saint-Luc, Bruxelles

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02360540     History of Changes
Other Study ID Numbers: PHRC2014_02
First Posted: February 10, 2015    Key Record Dates
Last Update Posted: September 22, 2016
Last Verified: September 2016

Keywords provided by University Hospital, Angers:
Pulmonary Embolism
Diagnostic strategy
Exclusion
Clinical probability
Implicit Judgment (Gestalt)
PERC

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Dyspnea
Chest Pain
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Pain
Neurologic Manifestations
Nervous System Diseases