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

NCT06166329 — Not applicable, Recruiting, 180 participants, University Hospital, Rouen

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Registry	NCT06166329, acronym SIT-EP
Status	Recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, diagnostic
Enrollment	180 (Estimated)
Sponsor	University Hospital, Rouen (Other)
Conditions	Non-severe Pulmonary Embolism, Pulmonary Embolism, Non-high-risk Pulmonary Embolism, Pulmonary Embolism Acute, Prognostic Stratification, Risk Assessment in Pulmonary Embolism, Functional Exercise Testing, Early Prognostic Evaluation
Interventions	chair lift test (Other)
Dates	start 2024-02-09, primary completion 2027-02-01 (estimated), completion 2027-02-01 (estimated), first posted 2023-12-12, last updated 2026-02-17
Locations	1 site in France

-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

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+Arms and interventions

Arm	Type	Interventions	Description
chair lift test	Experimental	Other: chair lift test

chair lift test (Other): repetitions of the sit-stand position at a self-timed speed (safe and comfortable) as many times as possible for 1 minute

+Outcome measures

Primary outcomes

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 outcomes

Troponin measurement [1 day]
Presence or absence of post-pulmonary embolism dyspnea [6 months]
Overall survival [6 months]

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Chu Rouen	Rouen	France	Recruiting

+Investigators

Delphine SIMON, MD, Principal investigator, University Hospital, Rouen

My Notes

Public

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