Clinical Echography in Emergency Prognostic Evaluation of Pulmonary Embolism: ECU -EP Study.

Withdrawn

• Conditions: Embolism, Pulmonary
• Interventions: Procedure: clinical echography (CE)

• Registration Number: NCT03366519
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

Pulmonary Embolism (PE) is a frequent disease, the third cause of cardiovascular death after stroke and myocardial infarction. According to European guidelines of European Society of Cardiology (ESC) and of European Respiratory Society (ERS), the prognostic stratification of PE severity is mandatory as soon as PE is diagnosed. This stratification includes the hemodynamic status, and specific tools : the assessment of the sPESI score, and the evaluation of PE's impact on right ventricle (RV) : increased biomarkers (troponin, BNP) and right ventricle/left ventricle (RV/LV) ratio.

the RV/LV ration may be evaluated ideally by transthoracic echo (TTE), or by CT scan. Unfortunately, only 10% of patients with PE are evaluated with TTE by a cardiologist in the initial time of PE diagnosis. Hence, the CT scan is the most frequent way to assess RV/LV ratio. However, CT is not possible for all patients (patients with contra-indication) or may have difficulties to provide a clear assessment because of technical issues.

Then, there is a need for morphological evaluation of RV as soon as PE is diagnosed, in every clinical setting. The improvement in technologies allowed the development of clinical echography (CE) in emergency departments.

CE is already available, non-invasive, less expansive, and may be a good way to assess RV/LV ratio in patients with PE diagnosed in emergency departments.

The investigators propose a prospective, multicenter study to assess the sensitivity of CE in patients with PE, compared to CT scan to detect RV/LV ≥0.9.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-21
• Study First Submitted QC: 2017-12-07
• Study First Posted: 2017-12-08
• Study Start: 2018-11
• Primary Completion: 2018-12
• Study Completion: 2019-01
• Status Verified: 2019-03
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Adult patients with pulmonary embolism confirmed
• Simplified Pulmonary Embolism Severity Index (sPESI) ≥ 1

Exclusion Criteria

• Contra-indication to CT scanner
• Patients with high-risk pulmonary embolism (shock, hypotension)
• Simplified Pulmonary Embolism Severity Index (sPESI) =0

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with pulmonary embolism	clinical echography (CE)	patients with pulmonary embolism confirmed by tomography scan in emergency department

Primary Outcome Measures

Name	Time	Method
Patients with a measure RV/LV ratio ≥ 0.9 on clinical echography (CE) and CT Scan	day 1	Sensitivity of clinical echography (CE) to CT Scan to detect an increased RV/LV ratio above 0.9.

Secondary Outcome Measures

Name	Time	Method
Patients with a measure RV/LV ratio < 0.9 on clinical echography (CE) and CT Scan	day 1	Specificity of clinical echography (CE) to CT Scan to detect an increased RV/LV ratio below 0.9
Patients with abnormal inferior vena cava.	day 30
death	day 30