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

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.

Study Overview

• Status: Withdrawn
• Conditions: Embolism, Pulmonary
• Intervention / Treatment: Procedure: clinical echography (CE)

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients with a PE confirmed in emergency unit

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with pulmonary embolism; patients with pulmonary embolism confirmed by tomography scan in emergency department	Procedure: clinical echography (CE); clinical echography (CE) is performed in the first 24 hours following the diagnosis of PE, in emergency unit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Patients with abnormal inferior vena cava.		day 30
death		day 30

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Alain Viallon, MD PhD, Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2018
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: November 21, 2017
• First Submitted That Met QC Criteria: December 7, 2017
• First Posted (Actual): December 8, 2017

Study Record Updates

• Last Update Posted (Actual): April 4, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: prognosis; emergency; echocardiography; Embolism, Pulmonary
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Embolism and Thrombosis; Emergencies; Embolism; Pulmonary Embolism
• Other Study ID Numbers: 1608163; 2016-A01721-50 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No