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

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

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03366519
Acronym
ECU-EP
Enrollment
0
Registered
2017-12-08
Start date
2018-11-30
Completion date
2019-01-31
Last updated
2019-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Embolism, Pulmonary

Keywords

Embolism, Pulmonary, echocardiography, emergency, prognosis

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.

Interventions

PROCEDUREclinical echography (CE)

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

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Patients with a measure RV/LV ratio < 0.9 on clinical echography (CE) and CT Scanday 1Specificity 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
deathday 30

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026