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NCT Number: NCT06166329

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Rouen

Rouen, 76031, France

Location status: Recruiting

Location contact

Delphine Simon, Dr

CONTACT

[email protected]

Delphine Simon, Dr

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

    Time frame: 1 day

Secondary outcomes

  1. Troponin measurement

    Time frame: 1 day

  2. Presence or absence of post-pulmonary embolism dyspnea

    Time frame: 6 months

  3. Overall survival

    Time frame: 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Armelle GUIDOTTI

CONTACT

[email protected]

232888265 ext. +33

Delphine SIMON, MD

CONTACT

[email protected]

2 32 88 73 97 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: SIT-EP

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 12, 2023
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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