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

NCT03366519 | Withdrawn

• 2 other identifiers: 16081632016-A01721-50
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Keywords

Embolism, Pulmonary; echocardiography; emergency; prognosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Patients with a measure RV/LV ratio < 0.9 on clinical echography (CE) and CT Scan

  day 1

• Patients with abnormal inferior vena cava.

  day 30

• death

  day 30

Study Arms (1)

patients with pulmonary embolism

patients with pulmonary embolism confirmed by tomography scan in emergency department

Procedure: clinical echography (CE)

Interventions

clinical echography (CE) PROCEDURE

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

patients with pulmonary embolism

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with a PE confirmed in emergency unit

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

MeSH Terms

Conditions

Pulmonary Embolism; Emergencies

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alain Viallon, MD PhD

  Centre Hospitalier Universitaire de Saint Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: December 8, 2017
• Study Start: November 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2019
• Last Updated: April 4, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share