Early Prognostic Evaluation, Functional Exercise Testing, Non-high-risk Pulmonary Embolism, Non-severe Pulmonary Embolism, Prognostic Stratification, Pulmonary Embolism, Pulmonary Embolism Acute, Risk Assessment in Pulmonary Embolism
Conditions
Keywords
Pulmonary Embolism, Prognostic Evaluation, Risk Stratification, sPESI Score, Chair Stand Test, One-Minute Sit-to-Stand Test, Functional Capacity, Right Ventricular Dysfunction, Cardiac Biomarkers, Troponin, NT-proBNP, Early Mortality, Ambulatory Management, Hospitalized Patients
Brief summary
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
Interventions
OTHERchair lift test
repetitions of the sit-stand position at a self-timed speed (safe and comfortable) as many times as possible for 1 minute
Sponsors
University Hospital, Rouen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 1 day |
Secondary
| Measure | Time frame |
|---|---|
| Troponin measurement | 1 day |
| Presence or absence of post-pulmonary embolism dyspnea | 6 months |
| Overall survival | 6 months |
Countries
France
Contacts
CONTACTDelphine SIMON, MD
CONTACTArmelle GUIDOTTI
PRINCIPAL_INVESTIGATORDelphine SIMON, MD
University Hospital, Rouen
Outcome results
None listed