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

NCT ID: NCT06166329

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-20

Study Completion Date

2025-12-20

Brief Summary

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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

Detailed Description

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Conditions

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Non-severe Pulmonary Embolism

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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chair lift test

Group Type EXPERIMENTAL

chair lift test

Intervention Type OTHER

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

Interventions

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chair lift test

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Delphine SIMON, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Central Contacts

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Delphine SIMON, MD

Role: CONTACT

Phone: 2 32 88 73 97

Email: [email protected]

Armelle GUIDOTTI

Role: CONTACT

Phone: 232888265

Email: [email protected]

Other Identifiers

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2021/0386/HP

Identifier Type: -

Identifier Source: org_study_id