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 人开始时间: 2024年2月9日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 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
研究概览
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
Experimental
干预措施: chair lift test (Other)
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)
研究者
研究点 (1)
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