跳至主要内容
临床试验/NCT03366519
NCT03366519撤回不适用

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

Centre Hospitalier Universitaire de Saint Etienne0 个研究点开始时间: 2018年11月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Patients with a measure RV/LV ratio ≥ 0.9 on clinical echography (CE) and CT Scan

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

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

时间窗: day 1

Sensitivity of clinical echography (CE) to CT Scan to detect an increased RV/LV ratio above 0.9.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

相似试验

Clinical Echography in Emergency Prognostic... | 临床试验