Interest of the Chair Lift Test in the Prognostic Evaluation of Pulmonary Embolism: a Single-center Open Prospective Study (SIT-EP)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Armelle GUIDOTTI
- Phone Number: +33 232888265
- Email: armelle.guidotti@chu-rouen.fr
Study Contact Backup
- Name: Delphine SIMON, MD
- Phone Number: +33 2 32 88 73 97
- Email: delphine.simon@chu-rouen.fr
Study Locations
-
-
-
Rouen, France, 76031
- Recruiting
- CHU Rouen
-
Contact:
- Delphine Simon, Dr
- Email: Delphine.Simon@chu-rouen.fr
-
Principal Investigator:
- Delphine Simon, Dr
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: 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
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
1 day
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall survival
Time Frame: 6 months
|
6 months
|
|
Troponin measurement
Time Frame: 1 day
|
1 day
|
|
Presence or absence of post-pulmonary embolism dyspnea
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Delphine SIMON, MD, University Hospital, Rouen
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2021/0386/HP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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