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Enrolling by Invitation

NCT Number: NCT05942859

Applying Artificial Intelligence to the 12 Lead ECG for the Diagnosis of Pulmonary Hypertension: an Observational Study

The goal of this observational study is to apply Artificial Intelligence (AI) and machine learning technology to the resting 12-lead electrocardiogram (ECG) and assess whether it can assist doctors in the early diagnosis of Pulmonary Hypertension (PH). Early and accurate diagnosis is an important step for patients with PH. It helps provide effective treatments early which improve prognosis and quality of life. The main questions our study aims to answer are:

1. Can AI technology in the 12-lead ECG accurately predict the presence of PH? 2. Can AI technology in the 12-lead ECG identify specific sub-types of PH? 3. Can AI technology in the 12-lead ECG predict mortality in patients with PH?

In this study, the investigators will recruit 12-lead ECGs from consenting participants who have undergone Right heart Catheterisation (RHC) as part of their routine clinical care. AI technology will be applied to these ECGs to assess whether automated technology can predict the presence of PH and it's associated sub-types.

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Key information

Conditions

Pulmonary Hypertension (Diagnosis) Cardiovascular Diseases Disease Hypertension Hypertension, Pulmonary Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal United Hospital Bath NHS Trust

Bath, United Kingdom

About this study

This study will be led by Royal United Hospital Bath NHS Trust and Liverpool John Moore's University. The aim of this study is to utilise Artificial Intelligence (AI) and machine learning technology to assist clinicians in the early diagnosis of Pulmonary Hypertension (PH). We hypothesise that the AI technologies can improve the quantification and interpretation of the parameters involved in detecting PH. This is either through highlighting significant abnormalities in the 12-lead ECG, or by rapidly providing fully automated measures of the features on the 12-lead ECG which indicate PH. The combination of these electrocardiographic features with clinical data may provide highly accurate predictive tools.

This observational study will have a retrospective and prospective arm with a 3 year follow-up period. Participants will not require any additional tests or procedures at any point during the study. Any ECGs performed within the 12 months prior to a participant's right heart catheterisation (RHC) will undergo Artificial Intelligence analysis to establish if early indicators of PH are identifiable.

For all recruited participants, an anonymised clinician case report form will be used to capture details relating to their demographics and routine clinical care. Follow-up times and outcomes including mortality and morbidity will also be recorded.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • prospective cohort: From July 2023, all patients aged 18 or over who are referred to the Bath Pulmonary Hypertension shared care service with clinical suspicion of PH and, who through their routine clinical care, undergo a RHC and 12-lead ECG.
  • Retrospective cohort: All patients aged 18 or over who were referred to the local Pulmonary Hypertension shared care service between 2007 and June 2023, and through their routine clinical care, have undergone RHC within a year of a 12-lead ECG. This cohort will also include patients who are deceased.

Exclusion criteria

  • Patient's less than 18 years-old
  • Patients who do not give valid consent (except deceased patients; REC approved)
  • Patients who have not undergone RHC to assess for PH
  • Patients who have not had an ECG within 12 months of their RHC

Treatment and study plan

Artificial Intelligence and Machine Learning technology

Diagnostic Test

Artificial Intelligence describes computer software designed to mimic human cognitive function. Machine learning is a type of artificial intelligence in which the model created is exposed to data, identifies patterns, and recognises relationships between features seen in the data and the 'ground truth'. This technology will be applied to participants ECGs.

Primary outcomes

  1. Pulmonary Hypertension diagnosis

    Time frame: baseline

    The investigators will calculate the area under the receiver operating characteristic curve (AUROC) for PH diagnosis by artificial intelligence technology and compare this to RHC (the gold standard)

Secondary outcomes

  1. Pulmonary Hypertension sub-type

    Time frame: baseline

    The investigators will assess the diagnostic test accuracy of Artificial Intelligence technology to categorise participant ECGs according to Pulmonary Hypertension sub-type and compare this to standard clinical assessment

  2. Mortality

    Time frame: 3 years

    The investigators will calculate the area under the receiver operating characteristics curve (AUROC) for mortality as predicted by Artificial Intelligence technology

  3. Morbidity

    Time frame: baseline

    The investigators will calculate the area under the receiver operating characteristics curve for morbidity as predicted by Artificial Intelligence technology and compare this to current measures (NYHA functional class, 6MWT, Pulmonary function tests)

Sponsors and collaborators

Lead sponsor

Royal United Hospitals Bath NHS Foundation Trust

Other

Collaborators

  • Liverpool John Moores University

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2027
First posted
Jul 12, 2023
Registry last updated
Oct 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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