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

Embolism, Pulmonary Clinical Trial

— ECU-EP  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03366519
• Other study ID #: 1608163
• Secondary ID: 2016-A01721-50
• Status: Withdrawn
• Start date: November 2018
• Est. completion date: January 2019

Study information

• Verified date: March 2019
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Embolism
• Embolism, Pulmonary
• Emergencies
• Pulmonary Embolism

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients with a measure RV/LV ratio = 0.9 on clinical echography (CE) and CT Scan	Sensitivity of clinical echography (CE) to CT Scan to detect an increased RV/LV ratio above 0.9.	day 1
Secondary	Patients with a measure RV/LV ratio < 0.9 on clinical echography (CE) and CT Scan	Specificity of clinical echography (CE) to CT Scan to detect an increased RV/LV ratio below 0.9	day 1
Secondary	Patients with abnormal inferior vena cava.		day 30
Secondary	death		day 30