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

U

University Hospital, Rouen

Status

Not yet enrolling

Conditions

Non-severe Pulmonary Embolism

Treatments

Other: chair lift test

Study type

Interventional

Funder types

Other

Identifiers

NCT06166329
2021/0386/HP

Details and patient eligibility

About

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

Enrollment

180 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

180 participants in 1 patient group

chair lift test
Experimental group
Treatment:
Other: chair lift test

Trial contacts and locations

0

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Central trial contact

Armelle GUIDOTTI; Delphine SIMON, MD

Data sourced from clinicaltrials.gov

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