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WithdrawnNCT03366519ECU-EPUpdated Apr 4, 2019

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

An observational study in Embolism, Pulmonary, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-04.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Observational

Why this study was withdrawn
no open study
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Pulmonary Embolism by Centre Hospitalier Universitaire de Saint Etienne — 3 open to participants now, 3 under way, 1 of them phase 3. Pulmonary Embolism · Centre Hospitalier Universitaire de Saint Etienne.

Started
2018
the only one that year
Observational
4 of 10
1 open now
Registered
5th of 10
by date

Among the 10 studies in Pulmonary Embolism by Centre Hospitalier Universitaire de Saint Etienne, this one is the only one that started in 2018, is one of 4 observational ones, and was the 5th registered.

By phase

10 studies; the count open now beside each. This study's row is marked.

Observationalthis study4 · 1 open
Other kind2 · 0 open
Phase 32 · 1 open
No phase1 · 1 open
Phase 41 · 0 open

By the year they started

First in 2006; this study’s year is marked. 1 started in 2018.

Size and results

Median enrollment 306 across the 4 interventional studies, 103 across the 6 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 10 studies in Pulmonary Embolism by Centre Hospitalier Universitaire de Saint Etienne, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Embolism, Pulmonary

Keywords

  • Embolism, Pulmonary
  • echocardiography
  • emergency
  • prognosis
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients with a PE confirmed in emergency unit

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • to CT scanner
  • Patients with high-risk pulmonary embolism (shock, hypotension)
  • Simplified Pulmonary Embolism Severity Index (sPESI) =0
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No

Groups and cohorts

  • patients with pulmonary embolism

    patients with pulmonary embolism confirmed by tomography scan in emergency department

    Procedure: clinical echography (CE)

Interventions

  • Procedureclinical echography (CE)

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

06

What researchers measure

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.

    Time frame: day 1

Secondary outcomes

  1. 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

    Time frame: day 1

  2. Patients with abnormal inferior vena cava.

    Time frame: day 30

  3. death

    Time frame: day 30

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03366519
Responsible party
Sponsor
First posted
Dec 8, 2017
Start date
Nov 2018 (estimated)
Primary completion
Dec 2018 (estimated)
Completion
Jan 2019 (estimated)
Last update
Apr 4, 2019

Study contacts

Alain Viallon, MD PhD
principal investigator · Centre Hospitalier Universitaire de Saint Etienne

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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