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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United Kingdom

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.

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 groups in NCT06093217
Study groupRoleWhat they receive
Prospective Cohort: 'Live' Introduction of AI technologyConsecutive 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 reportingRetrospective 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.

  1. 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)
  1. Rate of acute PE detection with AI technology

    True positives and True negatives

    Measured: 24 months

  2. Rate of discordant acute PE cases

    False positive and false negative rate with acute PE detection

    Measured: 24 months

  3. AI failure rate for acute PE detection

    Proportion of scans unable to be interpreted by AI despite suitable CTPA acquisition

    Measured: 24 months

  4. Rate of RV:LV detection with AI technology

    True positive and true negative

    Measured: 24 months

  5. Rate of discordant RV:LV detection

    False positive and false negative

    Measured: 24 months

  6. Failure rate for automated RV:LV ratio

    Proportion of scans unable to calculate automated RV:LV ratio despite suitable CTPA acquisition

    Measured: 24 months

  7. 30 day mortality

    Patient mortality (death) at 30-days post-PE diagnosis. Comparison before and after AI introduction.

    Measured: 12 months

  8. 12 month mortality

    Patient mortality (death) at 12-months post-PE diagnosis. Comparison before and after AI introduction.

    Measured: 12 months

  9. Hospital admission and bed days for acute PE

    Comparison before and after AI introduction

    Measured: 12 months

  10. Time to anticoagulation in PE cases

    Comparison before and after AI introduction

    Measured: 12 months

  11. Time from CTPA to discharge

    Comparison before and after AI introduction

    Measured: 12 months

  12. PE risk stratification rates (low, intermediate low, intermediate high and high risk)

    Comparison before and after AI introduction

    Measured: 12 months

  13. Cost to NHS for acute PE

    Comparison before and after AI introduction

    Measured: 12 months

  14. 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

  15. Referral rates to outpatient follow-up (respiratory, thrombosis, haematology)

    Comparison before and after AI introduction

    Measured: 12 months

  16. 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.

  1. First posted23 Oct 2023
  2. Study start8 Jan 2024
  3. Primary completion8 Jan 2025
  4. Study completion6 Feb 2025

Resources

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)
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

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.

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