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
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|
|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|
|Primary Completion Date :||July 2016|
|Study Completion Date :||July 2016|
- 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
- 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
- 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.
- 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
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
|Clinique Universitaire Saint-Luc|
|Hospital of Agen|
|Hospital of Argenteuil|
|Hospital of Le Mans|
|Le Mans, France|
|Hospital of Saint-Brieuc|
|Study Chair:||Pierre-Marie ROY, MD-PhD||UH Angers|
|Study Director:||Andréa PENALOZA, MD-PhD||Clinique Universitaire Saint-Luc, Bruxelles|