Pulmonary EmbolismTOMOBSNCT03657992
Time Trend Analysis of PE Diagnosis With SPECT V/Q: a Single Institution Observational Study
An observational study of Pulmonary Embolism, run by University Hospital, Brest at 1 site in France.
Trial summary
Following the implementation of SPECT V/Q imaging for PE diagnosis, the investigators previously conducted an observational study over the period 2011-2013 that showed the safety of a diagnostic management based on SPECT V/Q to rule out PE. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2018to 30 May 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent a SPECT V/Q scan performed for a suspected acute PE in the Nuclear Medicine Department of Brest University Hospital from April 2011 to December 2016
Who may be able to join
- Patients who underwent a SPECT V/Q scan performed for a suspected acute PE in the Nuclear Medicine Department of Brest University Hospital from April 2011 to December 2016
Who cannot join
- Patient under legal or judicial protection
- Patient opposed to the use of his medical data for research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Time Trend Analysis of Pulmonary Embolism Diagnosis With SPECT V/Q: a Single Institution Observational Study From 2011 to 2016
Following the implementation of SPECT V/Q imaging for PE diagnosis, the investigators previously conducted an observational study over the period 2011-2013 that showed the safety of a diagnostic management based on SPECT V/Q to rule out PE. However, PE prevalence was high (28%), which may seem a bit high as compared with other recent studies. The hypothesis was that the use of SPECT V/Q may be responsible for an overdiagnosis of PE, especially at the implementation phase of the test. The aim of this study was to perform a time trend analysis of the evolution over the years of PE diagnosis with SPECT V/Q.
- Conditions
- Pulmonary Embolism
- Medical subject headings
- Pulmonary Embolism
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic conclusion of all SPECT V/Q scans performed for a suspected acute PE
positive, negative, or non-conclusive
Measured: April 2011 to December 2016
Secondary outcomes (1)
Risk of thromboembolic events (i.e. objectively confirmed pulmonary embolism or proximal deep vein thrombosis) during the 3-month follow-up period in patients left untreated based on a negative SPECT V/Q.
Measured: up to 3 Months following the date of the SPECT V/Q scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start1 Feb 2018
- Primary completion30 May 2018
- Study completion30 May 2018
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
- 2,000 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
- NCT03657992
- Sponsor's protocol ID
- TOMOBS (29BRC18.0017)
- Acronym
- TOMOBS
- Status last verified
- Aug 2018
- First submitted
- 30 Aug 2018
- Last updated
- 5 Sep 2018
- 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 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Trend Analysis of Pulmonary Embolism Diagnosis With SPECT V/Q: a Single Institution Observational Study From 2011 to 2016
- ClinicalTrials.gov ID
- NCT03657992
- Acronym / sponsor ID
- TOMOBS / TOMOBS (29BRC18.0017)
- Conditions
- Pulmonary Embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 30 May 2018 (actual)
- First posted
- 5 Sep 2018 (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.
Following the implementation of SPECT V/Q imaging for PE diagnosis, the investigators previously conducted an observational study over the period 2011-2013 that showed the safety of a diagnostic management based on SPECT V/Q to rule out PE. However, PE prevalence was high (28%), which may seem a bit high as compared with other recent studies. The hypothesis was that the use of SPECT V/Q may be responsible for an overdiagnosis of PE, especially at the implementation phase of the test. The aim of this study was to perform a time trend analysis of the evolution over the years of PE diagnosis with SPECT V/Q.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent a SPECT V/Q scan performed for a suspected acute PE in the Nuclear Medicine Department of Brest University Hospital from April 2011 to December 2016
Key inclusion criteria (1 listed)
- Patients who underwent a SPECT V/Q scan performed for a suspected acute PE in the Nuclear Medicine Department of Brest University Hospital from April 2011 to December 2016
Key exclusion criteria (2 listed)
- Patient under legal or judicial protection
- Patient opposed to the use of his medical data for research.
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
Diagnostic conclusion of all SPECT V/Q scans performed for a suspected acute PE
Time frame: April 2011 to December 2016
positive, negative, or non-conclusive
1 secondary outcome
Risk of thromboembolic events (i.e. objectively confirmed pulmonary embolism or proximal deep vein thrombosis) during the 3-month follow-up period in patients left untreated based on a negative SPECT V/Q.
Time frame: up to 3 Months following the date of the SPECT V/Q 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 5 Sep 2018.
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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 University Hospital, Brest 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 2 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 5 Sep 2018. 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?
Diagnostic conclusion of all SPECT V/Q scans performed for a suspected acute PE (time frame: April 2011 to December 2016). 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 5 Sep 2018.