Clinical trial NCT03366519: Clinical Echography in Emergency Prognostic Evaluation of Pulmonary Embolism: ECU -EP Study.
Official title: Clinical Echography in Emergency Prognostic Evaluation of Pulmonary Embolism: ECU -EP Study.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Embolism, Pulmonary
Keywords: Embolism, Pulmonary
echocardiography
emergency
prognosis
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2017-12-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with a PE confirmed in emergency unit

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.


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

Primary outcomes:
measure: Patients with a measure RV/LV ratio ≥ 0.9 on clinical echography (CE) and CT Scan
timeFrame: day 1
Secondary outcomes:
measure: Patients with a measure RV/LV ratio < 0.9 on clinical echography (CE) and CT Scan
timeFrame: day 1
measure: Patients with abnormal inferior vena cava.
timeFrame: day 30
measure: death
timeFrame: day 30
Other outcomes:
Locations:
Study officials:
affiliation: Centre Hospitalier Universitaire de Saint Etienne
name: Alain Viallon, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: