Pulmonary EmbolismSCINTI-COVIDNCT05353608
Lung Scintigraphy for Pulmonary Embolism Diagnosis in COVID-19 Patients.
An observational study of Pulmonary Embolism and COVID-19, run by University Hospital, Brest at 2 sites in France.
Trial summary
A frequent complication of COVID-19 disease is pulmonary embolism (PE). Lung ventilation/perfusion (V/P) scintigraphy is a well-established test for PE diagnosis. The test is interpreted based on the recognition of wedge shaped perfusion mismatched defects. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pulmonary Embolism, COVID-19
- How many people
- 183 participants
- Where
- 2 sitesFrance
- Study dates
- 30 Apr 2021to 31 May 2021
- 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 18 to 99 years
- All sexes
- Adult, Older adult
Study population: COVID-19 patients who underwent lung scintigraphy for suspected PE.
Who may be able to join
- Patients with suspected COVID-19 disease
- Referred for lung scintigraphy for suspected acute PE
Who cannot join
- Patient under guardianship or curatorship
- Patient deprived of liberty by an administrative or judicial decision
- Inability or refuse to give consent
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Lung Scintigraphy for Pulmonary Embolism Diagnosis in COVID-19 Patients: a Multicenter Observational Study.
A frequent complication of COVID-19 disease is pulmonary embolism (PE).
Lung ventilation/perfusion (V/P) scintigraphy is a well-established test for PE diagnosis. The test is interpreted based on the recognition of wedge shaped perfusion mismatched defects. However, the ventilation procedure increases the potential risk of contamination by the aerosol secretion and the expired air.
Read more
A variety of strategies have been proposed in the nuclear medicine literature regarding performance of lung ventilation scintigraphy in COVID-19 patients with suspected acute PE. However, there is currently no factual data in this specific population to support recommendations to the nuclear medicine community.
The aim of this study was to assess the role of ventilation imaging when performing lung scintigraphy for suspected PE in COVID-19 patients.
- Conditions
- Pulmonary Embolism, COVID-19
- Keywords
- Lung scintigraphy
- Medical subject headings
- Pulmonary Embolism, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
PE diagnosis on lung scintigraphy without the ventilation scan.
Percentage of scans for which the diagnostic conclusion of the lung scan would have been different when omitting the ventilation scan
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start30 Apr 2021
- Primary completion31 May 2021
- Study completion31 May 2021
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 University Hospital, BrestThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05353608
- Sponsor's protocol ID
- SCINTI-COVID (29BRC21.0143)
- Acronym
- SCINTI-COVID
- Status last verified
- Apr 2022
- First submitted
- 27 Apr 2022
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Scintigraphy for Pulmonary Embolism Diagnosis in COVID-19 Patients: a Multicenter Observational Study.
- ClinicalTrials.gov ID
- NCT05353608
- Acronym / sponsor ID
- SCINTI-COVID / SCINTI-COVID (29BRC21.0143)
- Conditions
- Pulmonary Embolism, COVID-19
- Keywords
- Lung scintigraphy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 29 Apr 2022 (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.
A frequent complication of COVID-19 disease is pulmonary embolism (PE).
Lung ventilation/perfusion (V/P) scintigraphy is a well-established test for PE diagnosis. The test is interpreted based on the recognition of wedge shaped perfusion mismatched defects. However, the ventilation procedure increases the potential risk of contamination by the aerosol secretion and the expired air.
A variety of strategies have been proposed in the nuclear medicine literature regarding performance of lung ventilation scintigraphy in COVID-19 patients with suspected acute PE. However, there is currently no factual data in this specific population to support recommendations to the nuclear medicine community.
The aim of this study was to assess the role of ventilation imaging when performing lung scintigraphy for suspected PE in COVID-19 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- COVID-19 patients who underwent lung scintigraphy for suspected PE.
Key inclusion criteria (2 listed)
- Patients with suspected COVID-19 disease
- Referred for lung scintigraphy for suspected acute PE
Key exclusion criteria (3 listed)
- Patient under guardianship or curatorship
- Patient deprived of liberty by an administrative or judicial decision
- Inability or refuse to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
PE diagnosis on lung scintigraphy without the ventilation scan.
Time frame: 1 day
Percentage of scans for which the diagnostic conclusion of the lung scan would have been different when omitting the ventilation scan
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 9 Aug 2024.
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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.
2 sites 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 and COVID-19, run by University Hospital, Brest at 2 sites 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 2 inclusion and 3 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 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
PE diagnosis on lung scintigraphy without the ventilation scan. (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 9 Aug 2024.