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

NCT ID: NCT03366519

Last Updated: 2019-04-04

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-30
• Study Completion Date: 2019-01-31

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.

Conditions

Embolism, Pulmonary

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

patients with pulmonary embolism

patients with pulmonary embolism confirmed by tomography scan in emergency department

clinical echography (CE)

Intervention Type: PROCEDURE

clinical echography (CE) is performed in the first 24 hours following the diagnosis of PE, in emergency unit

Interventions

clinical echography (CE)

clinical echography (CE) is performed in the first 24 hours following the diagnosis of PE, in emergency unit

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alain Viallon, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Saint Etienne

Other Identifiers

2016-A01721-50

Identifier Type: OTHER

Identifier Source: secondary_id

1608163

Identifier Type: -

Identifier Source: org_study_id