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| Name | Class |
|---|---|
| Liverpool John Moores University | OTHER |
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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective Cohort | Patients who have previously been seen by the local Pulmonary Hypertension service, between 2007 and June 2023, for a suspected diagnosis of pulmonary hypertension, and undergone Right Heart Catheterisation (RHC) will be invited to participate in the study by a member of the direct clinical care team. Their ECG will be analysed using AI technology to develop an algorithm to aid the diagnosis of PH. |
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| Prospective Cohort | Patients who are referred to the local PH service, from July 2023, with a suspected diagnosis of pulmonary hypertension, and undergo Right Heart Catheterisation will be invited to participate in the study by a member of the direct clinical care team. Their ECG will be analysed using AI technology to develop an algorithm to aid the diagnosis of PH. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary Hypertension diagnosis | 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) | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary Hypertension sub-type | 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 | baseline |
| Mortality |
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Inclusion Criteria:
Exclusion Criteria:
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Patients, aged 18 or over, who have a clinical suspicion of Pulmonary Hypertension and undergo Right Heart Catheterisation within 12 months of an ECG.
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| Name | Affiliation | Role |
|---|---|---|
| Dan Augustine, BSc, MBBS, MRCP | Royal United Bath NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal United Hospital Bath NHS Trust | Bath | United Kingdom |
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The investigators will calculate the area under the receiver operating characteristics curve (AUROC) for mortality as predicted by Artificial Intelligence technology |
| 3 years |
| Morbidity | 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) | baseline |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D004194 | Disease |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001185 | Artificial Intelligence |
| ID | Term |
|---|---|
| D000465 | Algorithms |
| D055641 | Mathematical Concepts |
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