- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06473610
Residual Embolism Evaluated With Single Photon Emission Computed Tomography (RESPECT)
August 4, 2025 updated by: Centre Hospitalier Universitaire de Saint Etienne
Residual Embolism Evaluated With Single Photon Emission Computed Tomography - The RESPECT Cohort
Major progress achieved in diagnostic and therapeutic strategies has substantially improved the short-term prognosis of patients with pulmonary embolism (PE).
These improvements have led to a shift from an acute to a chronic condition of venous thromboembolism, justifying the recent development of Chronic Thrombo-embolic Disease (CTED).
In most of the situations, it is due to a residual pulmonary vascular obstruction (RPVO) which can be assessed by pulmonary scintigraphy.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Planar ventilation/perfusion (V/Q) scintigraphy is the gold standard, but for several months, V/Q single photon emission computed tomography (SPECT) is recommended in the guidelines.
The aim of this study is to evaluate the performances of various SPECT protocols to quantified RPVO and compared to planar scintigraphy to evaluate the RPVO.
Study Type
Observational
Enrollment (Estimated)
358
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Pierre-Benoit BONNEFOY, MD
- Phone Number: +33 (0)4 77 82 94 43
- Email: pierre-benoit.bonnefoy@chu-st-etienne.fr
Study Contact Backup
- Name: NATHALIE PREVOT, MD
- Phone Number: +33 (0)4 77 82 94 43
- Email: nathalie.prevot@chu-st-etienne.fr
Study Locations
-
-
-
Saint-Étienne, France, 42055
- Recruiting
- Centre Hospitalier Universitaire
-
Principal Investigator:
- Pierre-Benoit BONNEFOY, MD
-
Sub-Investigator:
- Nathalie PREVOT, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with V/Q pulmonary SPECT-CT assess to rule out perfusion obstruction, patients admitted for a suspicion of PH, or a persistent dyspnea after PE
Description
Inclusion Criteria:
- Patient addressed to nuclear medicine department of Saint-Etienne public hospital for V/Q pulmonary SPECT-CT assess to rule out perfusion obstruction, admitted for a suspicion of pulmonary hypertension (PH), or a persistent dyspnea after PE
- Patient affiliated ou beneficiary of social security.
Exclusion Criteria:
- Pregnant patient.
- Patient addressed to nuclear medicine department for acute pulmonary embolism.
- Impossibility of the entire protocol acquisitions realization.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
RPVO (%)
Time Frame: At inclusion
|
Evaluation of the RPVO establish with Meyer score (planar scintigraphy, 2D).
The higher the percentage, the greater the obstruction of the lung
|
At inclusion
|
|
Segmental visual score
Time Frame: At inclusion
|
Evaluation of segmental visual score (SPECT-CT , 3D) The higher the percentage, the greater the obstruction of the lung
|
At inclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Pierre-Benoit BONNEFOY, MD, CENTRE HOSPITALIER DE SAINT-ETIENNE
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 27, 2024
Primary Completion (Estimated)
April 1, 2026
Study Completion (Estimated)
April 1, 2026
Study Registration Dates
First Submitted
June 19, 2024
First Submitted That Met QC Criteria
June 19, 2024
First Posted (Actual)
June 25, 2024
Study Record Updates
Last Update Posted (Actual)
August 7, 2025
Last Update Submitted That Met QC Criteria
August 4, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23CH190
- 2024-A00613-44 (Other Identifier: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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