Non-severe Pulmonary EmbolismSIT-EPNCT06166329
Interest of the Chair Lift Test in the Prognostic Evaluation of Pulmonary Embolism: a Single-center Open Prospective Study
A study testing chair lift test in people with Non-severe Pulmonary Embolism and Pulmonary Embolism, run by University Hospital, Rouen at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-severe Pulmonary Embolism, Pulmonary Embolism, Non-high-risk Pulmonary Embolism
- What is being tested?
- chair lift test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 9 Feb 2024to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu Rouen
Rouen, 76031
Delphine Simon, Dr, Delphine.Simon@chu-rouen.fr
Delphine Simon, Dr
About this 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
- Conditions
- Non-severe Pulmonary Embolism, Pulmonary Embolism, Non-high-risk Pulmonary Embolism, Pulmonary Embolism Acute, Prognostic Stratification, Risk Assessment in Pulmonary Embolism
- Being tested
- chair lift test
- Keywords
- Pulmonary Embolism, Prognostic Evaluation, Risk Stratification, sPESI Score, Chair Stand Test, One-Minute Sit-to-Stand Test, Functional Capacity, Right Ventricular Dysfunction, Cardiac Biomarkers, Troponin, NT-proBNP, Early Mortality, Ambulatory Management, Hospitalized Patients
- Medical subject headings
- Pulmonary Embolism, Ventricular Dysfunction, Right
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chair lift testOther
repetitions of the sit-stand position at a self-timed speed (safe and comfortable) as many times as possible for 1 minute
| Study group | Role | What they receive |
|---|---|---|
| chair lift test | Experimental | Not described Receives: Other: chair lift test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Secondary outcomes (3)
Troponin measurement
Measured: 1 day
Presence or absence of post-pulmonary embolism dyspnea
Measured: 6 months
Overall survival
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start9 Feb 2024
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-severe Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Delphine SIMON, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166329
- Sponsor's protocol ID
- 2021/0386/HP
- Acronym
- SIT-EP
- Status last verified
- Feb 2026
- First submitted
- 4 Dec 2023
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of the Chair Lift Test in the Prognostic Evaluation of Pulmonary Embolism: a Single-center Open Prospective Study
- ClinicalTrials.gov ID
- NCT06166329
- Acronym / sponsor ID
- SIT-EP / 2021/0386/HP
- Conditions
- Non-severe Pulmonary Embolism, Pulmonary Embolism, Non-high-risk Pulmonary Embolism, Pulmonary Embolism Acute, Prognostic Stratification, Risk Assessment in Pulmonary Embolism
- Keywords
- Pulmonary Embolism, Prognostic Evaluation, Risk Stratification, sPESI Score, Chair Stand Test, One-Minute Sit-to-Stand Test, Functional Capacity, Right Ventricular Dysfunction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 9 Feb 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 12 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chair lift test | Experimental | Other: chair lift test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chair lift testrepetitions of the sit-stand position at a self-timed speed (safe and comfortable) as many times as possible for 1 minute | Other | chair lift test |
Primary outcome
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
3 secondary outcomes
Troponin measurement
Time frame: 1 day
Presence or absence of post-pulmonary embolism dyspnea
Time frame: 6 months
Overall survival
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Non-severe Pulmonary Embolism
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
Recruiting
Evaluation of the Effectiveness of Intensive Medical Follow-up with an Advanced Practice Nurse Compared with Medical Follow-up Alone in Non-severe Pulmonary Embolism.
Non-severe Pulmonary Embolism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Delphine SIMON, MD principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chair lift test in people with Non-severe Pulmonary Embolism and Pulmonary Embolism, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Delphine SIMON, MD (2 32 88 73 97 ext. +33, delphine.simon@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.