Pulmonary EmbolismNCT04654156
Assessment of Contrast Enhancement Boost for the Direct Identification of Pulmonary Emboli in Thoracic CT Angiography
An observational study of Pulmonary Embolism, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Pulmonary embolism is a common cardiovascular disease and thoracic CT angiography is currently considered the gold standard for its non-invasive diagnosis. However, the diagnostic performance of CT angiography can be hampered by an insufficient enhancement of pulmonary arteries. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Contrast Boost post processing technique
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2019to 1 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patient referred in our institution by emergency practitioners who underwent thoracic CT angiography for clinical suspicion of pulmonary embolism between March and June 2018
Who may be able to join
- Patient who underwent thoracic CT angiography for suspicion of pulmonary embolism in our institution between March and June 2018
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Pulmonary embolism is a common cardiovascular disease and thoracic CT angiography is currently considered the gold standard for its non-invasive diagnosis. However, the diagnostic performance of CT angiography can be hampered by an insufficient enhancement of pulmonary arteries. Contrast Enhancement Boost (CE Boost) is a post-processing technique using an iodine density map to artificially improve pulmonary artery enhancement.
This retrospective study compares standard CT-angiography images with CE Boost images to assess the potential improvement of diagnostic performance for the detection of pulmonary embolism.
- Conditions
- Pulmonary Embolism
- Being tested
- Contrast Boost post processing technique
- Keywords
- Pulmonary embolism
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast Boost post processing techniqueDiagnostic test
Contrast Enhancement Boost is a post-processing technique that uses an iodine density map generated by subtracting a pre- and post-contrast CT acquisition to artificially enhance pulmonary artery enhancement.
| Study group | Role | What they receive |
|---|---|---|
| Pathological group | Patients with pulmonary embolism on thoracic CT angiography Receives: Diagnostic Test: Contrast Boost post processing technique | |
| Healthy group | Patients without pulmonary embolism on thoracic CT angiography Receives: Diagnostic Test: Contrast Boost post processing technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of thrombi within each branch of the pulmonary arteries
The pulmonary arteries were divided into 11 zones according to their anatomical characteristics then each visible thrombus was reported in a Excel table according to the zone where it was located
Measured: Between March and June 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start1 Jan 2019
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pedro TEIXEIRA-GONDIM, MD, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654156
- Sponsor's protocol ID
- 2020PI216
- Status last verified
- Nov 2020
- First submitted
- 6 Oct 2020
- Last updated
- 4 Dec 2020
- 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 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Contrast Enhancement Boost for the Direct Identification of Pulmonary Emboli in Thoracic CT Angiography
- ClinicalTrials.gov ID
- NCT04654156
- Acronym / sponsor ID
- 2020PI216
- Conditions
- Pulmonary Embolism
- Keywords
- Pulmonary embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 4 Dec 2020 (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.
Pulmonary embolism is a common cardiovascular disease and thoracic CT angiography is currently considered the gold standard for its non-invasive diagnosis. However, the diagnostic performance of CT angiography can be hampered by an insufficient enhancement of pulmonary arteries. Contrast Enhancement Boost (CE Boost) is a post-processing technique using an iodine density map to artificially improve pulmonary artery enhancement.
This retrospective study compares standard CT-angiography images with CE Boost images to assess the potential improvement of diagnostic performance for the detection of pulmonary embolism.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pathological group | – | Diagnostic Test: Contrast Boost post processing techniquePatients with pulmonary embolism on thoracic CT angiography |
| Healthy group | – | Diagnostic Test: Contrast Boost post processing techniquePatients without pulmonary embolism on thoracic CT angiography |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient referred in our institution by emergency practitioners who underwent thoracic CT angiography for clinical suspicion of pulmonary embolism between March and June 2018
Key inclusion criteria (1 listed)
- Patient who underwent thoracic CT angiography for suspicion of pulmonary embolism in our institution between March and June 2018
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Contrast Boost post processing techniqueContrast Enhancement Boost is a post-processing technique that uses an iodine density map generated by subtracting a pre- and post-contrast CT acquisition to artificially enhance pulmonary artery enhancement. | Diagnostic test | Healthy group, Pathological group |
Primary outcome
Number of thrombi within each branch of the pulmonary arteries
Time frame: Between March and June 2018
The pulmonary arteries were divided into 11 zones according to their anatomical characteristics then each visible thrombus was reported in a Excel table according to the zone where it was located
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism, run by Central Hospital, Nancy, France 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 4 Dec 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of thrombi within each branch of the pulmonary arteries (time frame: Between March and June 2018). 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 4 Dec 2020.