Pulmonary EmbolismAID-PENCT06093217
Artificial Intelligence to Improve Detection and Risk Stratification of Acute Pulmonary Embolism (AID-PE)
An observational study of Pulmonary Embolism, run by Royal United Hospitals Bath NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The goal of this exploratory observational study is to assess the feasibility and real-world clinical impact of implementing Artificial Intelligence (AI) software for the detection of acute Pulmonary Embolism (PE) in patients who undergo Computed Tomography Pulmonary Angiogram (CTPA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Artificial Intelligence
- Type of treatment
- Medical device
- How many people
- 3,872 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Jan 2024to 6 Feb 2025
- 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: Adult patients who attend the Royal United Hospital Bath NHS Trust and require CTPA to exclude or diagnose acute PE.
Who may be able to join
- Patients over 18 years of age
- Patient requiring CTPA to exclude or diagnose acute PE
Who cannot join
- Patients under 18 years of age
- Patients who have registered with the national opt-out scheme for research
- CTPA performed for reasons other than acute PE
- CTPA performed for acute PE but reported by external radiologists
- Incomplete or discontinued CTPA scans
- Insufficient quality CTPA to allow for analysis by a radiologist
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal United Hospitals, Bath NHS Foundation Trust
Bath, BA1 3NG
About this study
Official title: Developing Artificial Intelligence Solutions to Improve Diagnosis and Risk Stratification in Acute Pulmonary Embolism
The goal of this exploratory observational study is to assess the feasibility and real-world clinical impact of implementing Artificial Intelligence (AI) software for the detection of acute Pulmonary Embolism (PE) in patients who undergo Computed Tomography Pulmonary Angiogram (CTPA). The main questions that this study aims to answer are:
[Question 1] What is the real-world impact of AI on the clinical outcomes and decision making by radiologists and clinicians in the management of acute PE?
Read more
[Question 2] Is AI software for the detection of acute PE acceptable to use in clinical practice and do they have a favourable impact on clinical workload?
[Question 3] Is it cost-effective to implement AI software for the detection of acute PE in clinical practice?
Patients having a CTPA for the detection of acute PE will have their imaging analysed by AI software in combination with a human radiologist. Researchers will aim to compare the clinical and radiology specific outcomes with a retrospective cohort of patients who have had standard routine radiology reporting.
Read the detailed description
Acute Pulmonary Embolism (PE) results from partial or total occlusion of the pulmonary blood vessels by thrombus, which can cause right ventricular failure and death if not diagnosed and treated early. Acute PE is a common condition with rising mortality. Patients with acute PE are often poorly risk stratified despite clear guidelines. In fact, the 2019 National Confidential Inquiry into Patient related Outcome and Death (NCEPOD) for acute PE highlighted the need to address worsening mortality rates through appropriate risk stratification of the condition.
ESC/ERS guidelines for the diagnosis and management of acute PE also advise on the importance of risk stratification. An increased right ventricle: left ventricle (RV:LV) ratio >1.0 on Computed Tomography Pulmonary Angiogram (CTPA) is associated 2.5-fold increased risk of all-cause mortality, and 5-fold risk for PE-related mortality. This metric is intended to help clinicians distinguish between patients with high and low risk acute PE. Patients stratified as high risk (RV:LV ratio >1.0) necessitate closer monitoring within an inpatient setting. Whereas, patients stratified as low risk (RV:LV ratio <1.0) are suitable for early discharge through ambulatory pathways.
Therefore, the provision of RV:LV metrics within radiology reporting has potentially important clinical implications. If clinicians are not provided with any quantifiable evidence of RV dysfunction on which to base their treatment decisions, patients with high risk acute PE may be unintentionally considered 'low risk' and discharged home. Furthermore, patients with low risk acute PE may be subject to longer, and potentially unnecessary, inpatient stays which undoubtedly contributes to the cost of healthcare. The integration of Artificial Intelligence (AI) technology within radiology reporting of CTPAs for acute PE could be a potential solution to address this challenge.
AI is an increasingly attractive technology within healthcare. It describes a number of computer software techniques which mimic human cognitive function. AI shows promise in ability to detect and risk stratify acute PE. However, most studies have been conducted in retrospective cohorts. Furthermore, no study current has addressed the health economic impact of implementing AI technology within the real-world reporting of acute PE.
This observational study will be led by Royal United Hospital Bath NHS Trust (RUH). The aim of this study is to integrate Artificial Intelligence and machine learning technology within the reporting of CTPAs for acute PE. The investigators hypothesise that AI technology can improve the prompt diagnosis, risk stratification, and management of acute PE within a real-world clinical setting. The investigators also hypothesis that integration of AI technology is cost-effective, and acceptable to radiologists and clinicians.
Patients whose scans will be included in the study will be all those consecutively presenting to the RUH with a possible diagnosis of acute PE for 12 months before (comparator cohort) and 12 months after (intervention cohort) 'live' introduction of integrated AI technology reporting. For all recruited participants, an anonymised clinician case report form will be used to capture details relating to their demographics, clinical-radiological PE severity, their management, and outcomes including mortality at 12 months.
At the point of analysis, the investigators will perform adjustments/matching between the two cohorts for patient baseline characteristics. The investigators will also adjust for calendar time of recruitment, to account for temporal trends. Analysis between both cohorts will also allow development of a decision analysis model to assess the cost-effectiveness of integrated AI technology within CTPA report for acute PE. Clinician and radiologist questionnaires will be used to assess user acceptability.
- Conditions
- Pulmonary Embolism
- Being tested
- Artificial Intelligence
- Keywords
- Artificial Intelligence, Pulmonary Embolism, CTPA, Venous Thrombo-embolic disease
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial IntelligenceDevice
AI technology will generate a report with relevant key slice imaging identifying the presence of an acute pulmonary embolism and RV:LV ratio measurements to the radiologist
| Study group | Role | What they receive |
|---|---|---|
| Prospective Cohort: 'Live' Introduction of AI technology | Consecutive CTPAs, for patients with suspected acute PE, which have their imaging interpreted 'live' by AI technology. The radiologist will have ultimate responsibility for the report generated. Receives: Device: Artificial Intelligence | |
| Comparator Cohort: Standard Radiology reporting | Retrospective CTPAs, for patients with suspected acute PE, which have been reported by a human radiologist only.
These CTPAs will not be interpreted by AI technology 'live' BUT undergo analysis to help assess the sensitivity, specificity, false negative, false positive rates of AI technology. Receives: Device: Artificial Intelligence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patient decisions made in line with evidence based best practice guidelines after introducing AI technology within CTPA reporting
Comparison before and after AI introduction
Measured: 12 months
Secondary outcomes (16)
Rate of acute PE detection with AI technology
True positives and True negatives
Measured: 24 months
Rate of discordant acute PE cases
False positive and false negative rate with acute PE detection
Measured: 24 months
AI failure rate for acute PE detection
Proportion of scans unable to be interpreted by AI despite suitable CTPA acquisition
Measured: 24 months
Rate of RV:LV detection with AI technology
True positive and true negative
Measured: 24 months
Rate of discordant RV:LV detection
False positive and false negative
Measured: 24 months
Failure rate for automated RV:LV ratio
Proportion of scans unable to calculate automated RV:LV ratio despite suitable CTPA acquisition
Measured: 24 months
30 day mortality
Patient mortality (death) at 30-days post-PE diagnosis. Comparison before and after AI introduction.
Measured: 12 months
12 month mortality
Patient mortality (death) at 12-months post-PE diagnosis. Comparison before and after AI introduction.
Measured: 12 months
Hospital admission and bed days for acute PE
Comparison before and after AI introduction
Measured: 12 months
Time to anticoagulation in PE cases
Comparison before and after AI introduction
Measured: 12 months
Time from CTPA to discharge
Comparison before and after AI introduction
Measured: 12 months
PE risk stratification rates (low, intermediate low, intermediate high and high risk)
Comparison before and after AI introduction
Measured: 12 months
Cost to NHS for acute PE
Comparison before and after AI introduction
Measured: 12 months
End-user (clinician and radiologist) acceptability of AI technology
Quantified metrics from a non-validated questionnaire to evaluate end-use experience of integrated AI radiology reporting.
Measured: 12 months
Referral rates to outpatient follow-up (respiratory, thrombosis, haematology)
Comparison before and after AI introduction
Measured: 12 months
Diagnostic rate of Chronic thromboembolic pulmonary hypertension (CTEPH)
Comparison before and after AI introduction
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start8 Jan 2024
- Primary completion8 Jan 2025
- Study completion6 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies 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
- Other
- Enrolment
- 3,872 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal United Hospitals Bath NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bath, University of Bristol, London School of Hygiene and Tropical Medicine
- Responsible party
- Sponsor
- Investigators
- Jonathan Rodrigues, MBBS FRCR, Principal investigator, Royal United Hospitals Bath NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093217
- Sponsor's protocol ID
- 2720
- Other IDs
- 311735
- Acronym
- AID-PE
- Status last verified
- Feb 2025
- First submitted
- 4 Oct 2023
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gunning SGS, Page J, Rossdale J, Charters PFP, Hudson B, Lyen S, Mackenzie Ross R, Seatter A, Bartlett JW, Austin L, Myring G, McLeod H, Mitchell P, Stimpson D, Cookson A, Suntharalingam J, Rodrigues JCL. Artificial intelligence to improve the detection and risk stratification of acute pulmonary embolism (AID-PE): protocol for a pragmatic quasi-experimental comparator study. BMJ Open. 2026 Feb 12;16(2):e111826. doi: 10.1136/bmjopen-2025-111826.
PubMed 41688104
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Artificial Intelligence Solutions to Improve Diagnosis and Risk Stratification in Acute Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT06093217
- Acronym / sponsor ID
- AID-PE / 2720
- Conditions
- Pulmonary Embolism
- Keywords
- Artificial Intelligence, Pulmonary Embolism, CTPA, Venous Thrombo-embolic disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,872 participants (actual)
- Lead sponsor
- Royal United Hospitals Bath NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Bath, University of Bristol, London School of Hygiene and Tropical Medicine
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 8 Jan 2025 (actual)
- Study completion
- 6 Feb 2025 (actual)
- First posted
- 23 Oct 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 goal of this exploratory observational study is to assess the feasibility and real-world clinical impact of implementing Artificial Intelligence (AI) software for the detection of acute Pulmonary Embolism (PE) in patients who undergo Computed Tomography Pulmonary Angiogram (CTPA). The main questions that this study aims to answer are:
[Question 1] What is the real-world impact of AI on the clinical outcomes and decision making by radiologists and clinicians in the management of acute PE?
[Question 2] Is AI software for the detection of acute PE acceptable to use in clinical practice and do they have a favourable impact on clinical workload?
[Question 3] Is it cost-effective to implement AI software for the detection of acute PE in clinical practice?
Patients having a CTPA for the detection of acute PE will have their imaging analysed by AI software in combination with a human radiologist. Researchers will aim to compare the clinical and radiology specific outcomes with a retrospective cohort of patients who have had standard routine radiology reporting.
Detailed description
Acute Pulmonary Embolism (PE) results from partial or total occlusion of the pulmonary blood vessels by thrombus, which can cause right ventricular failure and death if not diagnosed and treated early. Acute PE is a common condition with rising mortality. Patients with acute PE are often poorly risk stratified despite clear guidelines. In fact, the 2019 National Confidential Inquiry into Patient related Outcome and Death (NCEPOD) for acute PE highlighted the need to address worsening mortality rates through appropriate risk stratification of the condition.
ESC/ERS guidelines for the diagnosis and management of acute PE also advise on the importance of risk stratification. An increased right ventricle: left ventricle (RV:LV) ratio >1.0 on Computed Tomography Pulmonary Angiogram (CTPA) is associated 2.5-fold increased risk of all-cause mortality, and 5-fold risk for PE-related mortality. This metric is intended to help clinicians distinguish between patients with high and low risk acute PE. Patients stratified as high risk (RV:LV ratio >1.0) necessitate closer monitoring within an inpatient setting. Whereas, patients stratified as low risk (RV:LV ratio <1.0) are suitable for early discharge through ambulatory pathways.
Therefore, the provision of RV:LV metrics within radiology reporting has potentially important clinical implications. If clinicians are not provided with any quantifiable evidence of RV dysfunction on which to base their treatment decisions, patients with high risk acute PE may be unintentionally considered 'low risk' and discharged home. Furthermore, patients with low risk acute PE may be subject to longer, and potentially unnecessary, inpatient stays which undoubtedly contributes to the cost of healthcare. The integration of Artificial Intelligence (AI) technology within radiology reporting of CTPAs for acute PE could be a potential solution to address this challenge.
AI is an increasingly attractive technology within healthcare. It describes a number of computer software techniques which mimic human cognitive function. AI shows promise in ability to detect and risk stratify acute PE. However, most studies have been conducted in retrospective cohorts. Furthermore, no study current has addressed the health economic impact of implementing AI technology within the real-world reporting of acute PE.
This observational study will be led by Royal United Hospital Bath NHS Trust (RUH). The aim of this study is to integrate Artificial Intelligence and machine learning technology within the reporting of CTPAs for acute PE. The investigators hypothesise that AI technology can improve the prompt diagnosis, risk stratification, and management of acute PE within a real-world clinical setting. The investigators also hypothesis that integration of AI technology is cost-effective, and acceptable to radiologists and clinicians.
Patients whose scans will be included in the study will be all those consecutively presenting to the RUH with a possible diagnosis of acute PE for 12 months before (comparator cohort) and 12 months after (intervention cohort) 'live' introduction of integrated AI technology reporting. For all recruited participants, an anonymised clinician case report form will be used to capture details relating to their demographics, clinical-radiological PE severity, their management, and outcomes including mortality at 12 months.
At the point of analysis, the investigators will perform adjustments/matching between the two cohorts for patient baseline characteristics. The investigators will also adjust for calendar time of recruitment, to account for temporal trends. Analysis between both cohorts will also allow development of a decision analysis model to assess the cost-effectiveness of integrated AI technology within CTPA report for acute PE. Clinician and radiologist questionnaires will be used to assess user acceptability.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective Cohort: 'Live' Introduction of AI technology | – | Device: Artificial IntelligenceConsecutive CTPAs, for patients with suspected acute PE, which have their imaging interpreted 'live' by AI technology. The radiologist will have ultimate responsibility for the report generated. |
| Comparator Cohort: Standard Radiology reporting | – | Device: Artificial IntelligenceRetrospective CTPAs, for patients with suspected acute PE, which have been reported by a human radiologist only. These CTPAs will not be interpreted by AI technology 'live' BUT undergo analysis to help assess the sensitivity, specificity, false negative, false positive rates of AI technology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who attend the Royal United Hospital Bath NHS Trust and require CTPA to exclude or diagnose acute PE.
Key inclusion criteria (2 listed)
- Patients over 18 years of age
- Patient requiring CTPA to exclude or diagnose acute PE
Key exclusion criteria (6 listed)
- Patients under 18 years of age
- Patients who have registered with the national opt-out scheme for research
- CTPA performed for reasons other than acute PE
- CTPA performed for acute PE but reported by external radiologists
- Incomplete or discontinued CTPA scans
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 |
|---|---|---|
| Artificial IntelligenceAI technology will generate a report with relevant key slice imaging identifying the presence of an acute pulmonary embolism and RV:LV ratio measurements to the radiologist | Device | Comparator Cohort: Standard Radiology reporting, Prospective Cohort: 'Live' Introduction of AI technology |
Primary outcome
Proportion of patient decisions made in line with evidence based best practice guidelines after introducing AI technology within CTPA reporting
Time frame: 12 months
Comparison before and after AI introduction
16 secondary outcomes
Rate of acute PE detection with AI technology
Time frame: 24 months
Rate of discordant acute PE cases
Time frame: 24 months
AI failure rate for acute PE detection
Time frame: 24 months
Rate of RV:LV detection with AI technology
Time frame: 24 months
Rate of discordant RV:LV detection
Time frame: 24 months
Failure rate for automated RV:LV ratio
Time frame: 24 months
30 day mortality
Time frame: 12 months
12 month mortality
Time frame: 12 months
Hospital admission and bed days for acute PE
Time frame: 12 months
Time to anticoagulation in PE cases
Time frame: 12 months
Time from CTPA to discharge
Time frame: 12 months
PE risk stratification rates (low, intermediate low, intermediate high and high risk)
Time frame: 12 months
Cost to NHS for acute PE
Time frame: 12 months
End-user (clinician and radiologist) acceptability of AI technology
Time frame: 12 months
Referral rates to outpatient follow-up (respiratory, thrombosis, haematology)
Time frame: 12 months
Diagnostic rate of Chronic thromboembolic pulmonary hypertension (CTEPH)
Time frame: 12 months
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 13 Feb 2025.
- Derived from this study: PubMed 41688104Gunning SGS, Page J, Rossdale J, Charters PFP, Hudson B, Lyen S, Mackenzie Ross R, Seatter A, Bartlett JW, Austin L, Myring G, McLeod H, Mitchell P, Stimpson D, Cookson A, Suntharalingam J, Rodrigues JCL. Artificial intelligence to improve the detection and risk stratification of acute pulmonary embolism (AID-PE): protocol for a pragmatic quasi-experimental comparator study. BMJ Open. 2026 Feb 12;16(2):e111826. doi: 10.1136/bmjopen-2025-111826.
- Individual participant dataSharing planned: Undecided
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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.
Jonathan Rodrigues, MBBS FRCR principal investigator
Royal United Hospitals Bath NHS Foundation Trust
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 Royal United Hospitals Bath NHS Foundation Trust at 1 site in United Kingdom.
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 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 13 Feb 2025. 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 United Kingdom. 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?
Proportion of patient decisions made in line with evidence based best practice guidelines after introducing AI technology within CTPA reporting (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06093217, which also lists 1 linked publication.
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 13 Feb 2025.