Pulmonary Embolism (Diagnosis)NCT05708794
Adjust-Unlikely PE
An observational study of Pulmonary Embolism (Diagnosis), run by Dr. Kerstin de Wit at 1 site in Canada.
Trial summary
The aim of this pilot study is to assess the feasibility of a larger study to determine the Adjust-Unlikely algorithm safety and efficiency for diagnosing PE. The pilot study objectives are to: 1. Determine study recruitment rate, per site, per month 2. Determine study 90-day loss to follow up rate 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism (Diagnosis)
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 23 Apr 2023to 22 Dec 2023
- 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 presenting to emergency departments and urgent care centres with symptoms of PE.
Who may be able to join
- Emergency physician decides to test for PE
Who cannot join
- Tested for PE without using the Adjust-Unlikely algorithm
- D-dimer level is known before Adjust-Unlikely assessment
- A new indication for anticoagulation on emergency department assessment (other than pulmonary embolism) in a patient not previously prescribed an anticoagulant
- Declines participation
- Is inaccessible for follow-up
- Has previously participated in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Assess Feasibility of Evaluating the Safety and Efficiency of a Simplified Diagnostic Approach for Pulmonary Embolism
The aim of this pilot study is to assess the feasibility of a larger study to determine the Adjust-Unlikely algorithm safety and efficiency for diagnosing PE.
The pilot study objectives are to:
Read more
- Determine study recruitment rate, per site, per month
- Determine study 90-day loss to follow up rate
- Estimate of the proportion of enrolled patients who test negative for PE at initial assessment using the Adjust-Unlikely rule
- Estimate of the Adjust-Unlikely algorithm efficiency
- Compare excluded and missed-eligible patients to study participants: age, sex and prevalence of PE diagnoses at initial testing.
The pilot study hypothesis is that the investigators can recruit at least 20 patients per month and successfully follow at least 90% of patients for 90 days.
- Conditions
- Pulmonary Embolism (Diagnosis)
- Keywords
- emergency medicine, standardization of practice, diagnostics evaluation
- Medical subject headings
- Pulmonary Embolism, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who have PE excluded by the Adjust-Unlikely algorithm and who are subsequently diagnosed with either PE or lower limb DVT.
Measured: 90 days following index presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start23 Apr 2023
- Primary completion8 Sep 2023
- Study completion22 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Embolism (Diagnosis)Studies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Kerstin de Wit
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network
- Responsible party
- Sponsor-investigator, Dr. Kerstin de Wit, Queen's University
- Investigators
- Kerstin de Wit, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708794
- Sponsor's protocol ID
- 4269
- Status last verified
- Feb 2024
- First submitted
- 23 Jan 2023
- Last updated
- 12 Feb 2024
- 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 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess Feasibility of Evaluating the Safety and Efficiency of a Simplified Diagnostic Approach for Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT05708794
- Acronym / sponsor ID
- 4269
- Conditions
- Pulmonary Embolism (Diagnosis)
- Keywords
- emergency medicine, standardization of practice, diagnostics evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Dr. Kerstin de WitUniversity, hospital or other
- Collaborators
- Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network
- Study start
- 23 Apr 2023 (actual)
- Primary completion
- 8 Sep 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 1 Feb 2023 (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.
The aim of this pilot study is to assess the feasibility of a larger study to determine the Adjust-Unlikely algorithm safety and efficiency for diagnosing PE.
The pilot study objectives are to:
- Determine study recruitment rate, per site, per month
- Determine study 90-day loss to follow up rate
- Estimate of the proportion of enrolled patients who test negative for PE at initial assessment using the Adjust-Unlikely rule
- Estimate of the Adjust-Unlikely algorithm efficiency
- Compare excluded and missed-eligible patients to study participants: age, sex and prevalence of PE diagnoses at initial testing.
The pilot study hypothesis is that the investigators can recruit at least 20 patients per month and successfully follow at least 90% of patients for 90 days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to emergency departments and urgent care centres with symptoms of PE.
Key inclusion criteria (1 listed)
- Emergency physician decides to test for PE
Key exclusion criteria (6 listed)
- Tested for PE without using the Adjust-Unlikely algorithm
- D-dimer level is known before Adjust-Unlikely assessment
- A new indication for anticoagulation on emergency department assessment (other than pulmonary embolism) in a patient not previously prescribed an anticoagulant
- Declines participation
- Is inaccessible for follow-up
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
The proportion of patients who have PE excluded by the Adjust-Unlikely algorithm and who are subsequently diagnosed with either PE or lower limb DVT.
Time frame: 90 days following index presentation
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 12 Feb 2024.
- 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.
Kerstin de Wit principal investigator
Queen's University
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 (Diagnosis), run by Dr. Kerstin de Wit at 1 site in Canada.
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 6 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 12 Feb 2024. 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 Canada. 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?
The proportion of patients who have PE excluded by the Adjust-Unlikely algorithm and who are subsequently diagnosed with either PE or lower limb DVT. (time frame: 90 days following index presentation). 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 12 Feb 2024.