NCT06166329

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress75%
Feb 2024Feb 2027

First Submitted

Initial submission to the registry

December 4, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 12, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

February 9, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

3 years

First QC Date

December 4, 2023

Last Update Submit

February 13, 2026

Conditions

Keywords

Pulmonary EmbolismPrognostic EvaluationRisk StratificationsPESI ScoreChair Stand TestOne-Minute Sit-to-Stand TestFunctional CapacityRight Ventricular DysfunctionCardiac BiomarkersTroponinNT-proBNPEarly MortalityAmbulatory ManagementHospitalized Patients

Outcome Measures

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

    1 day

Secondary Outcomes (3)

  • Troponin measurement

    1 day

  • Presence or absence of post-pulmonary embolism dyspnea

    6 months

  • Overall survival

    6 months

Study Arms (1)

chair lift test

EXPERIMENTAL
Other: chair lift test

Interventions

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

chair lift test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Rouen

Rouen, 76031, France

RECRUITING

MeSH Terms

Conditions

Pulmonary EmbolismVentricular Dysfunction, Right

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesVentricular DysfunctionHeart Diseases

Study Officials

  • Delphine SIMON, MD

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2023

First Posted

December 12, 2023

Study Start

February 9, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations