跳至主要内容
临床试验/NCT06166329
NCT06166329
招募中
不适用

Interest of the Chair Lift Test in the Prognostic Evaluation of Pulmonary Embolism: a Single-center Open Prospective Study

University Hospital, Rouen1 个研究点 分布在 1 个国家目标入组 180 人2024年2月9日

概览

阶段
不适用
干预措施
chair lift test
疾病 / 适应症
Non-severe Pulmonary Embolism
发起方
University Hospital, Rouen
入组人数
180
试验地点
1
主要终点
sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the one-minute chair rise test in comparison with the gold standard refined by the use of cardiac biomarkers and right ventricular dysfunction
状态
招募中
最后更新
2个月前

概览

简要总结

The objective of the study is to evaluate the prognostic performance of the chair lift test in the initial assessment of the severity of non-severe pulmonary embolism in hospitalized patients, in comparison with the current pulmonary embolism risk stratification score using the sPESI score refined by the use of cardiac biomarkers and right ventricular dysfunction

注册库
clinicaltrials.gov
开始日期
2024年2月9日
结束日期
2027年2月1日
最后更新
2个月前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

发起方
University Hospital, Rouen
责任方
Sponsor

入排标准

入选标准

  • Diagnosis of pulmonary embolism according to clinical algorithm, confirmed by thoracic angioscan or ventilation perfusion (V/P) scan,
  • Non-serious pulmonary embolism, not requiring intensive care (thrombectomy or fibrinolysis not considered).
  • sPESI score ≥ 1 \[or = 0 with elevated troponin or presence of markers of VD dysfunction, or = 0 with need for hospitalization due to comorbidities unrelated to PE (social isolation, comprehension disorders, intercurrent infection, chronic renal failure, advanced cancer...)
  • Patients with no contraindications to chair lift testing (no O2 at the time of testing).
  • Effective anticoagulation for at least 1 hour.

排除标准

  • sPESI score = 0 with outpatient referral.
  • Diagnostic confirmation of Pulmonia Embolism by thoracic angioscan or scintigraphy more than 24h after suspicion of diagnosis.
  • Hospitalization \> 24h after introduction of anticoagulation, with subsequent confirmation by scintigraphy.
  • Any sign of serious Pulmonia Embolism, requiring hospitalization in an intensive care unit.
  • Asymptomatic Pulmonia Embolism discovered by chance

研究组 & 干预措施

chair lift test

干预措施: chair lift test

结局指标

主要结局

sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the one-minute chair rise test in comparison with the gold standard refined by the use of cardiac biomarkers and right ventricular dysfunction

时间窗: 1 day

次要结局

  • Troponin measurement(1 day)
  • Overall survival(6 months)
  • Presence or absence of post-pulmonary embolism dyspnea(6 months)

研究点 (1)

Loading locations...

相似试验