Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2026-01-09 @ 6:55 AM
Study NCT ID:
NCT05942859
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-10-05
First Post:
2023-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Applying Artificial Intelligence to the 12 Lead ECG for the Diagnosis of Pulmonary Hypertension: an Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001185', 'term': 'Artificial Intelligence'}], 'ancestors': [{'id': 'D000465', 'term': 'Algorithms'}, {'id': 'D055641', 'term': 'Mathematical Concepts'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-04', 'studyFirstSubmitDate': '2023-07-04', 'studyFirstSubmitQcDate': '2023-07-04', 'lastUpdatePostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary Hypertension diagnosis', 'timeFrame': 'baseline', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'Pulmonary Hypertension sub-type', 'timeFrame': 'baseline', 'description': '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'}, {'measure': 'Mortality', 'timeFrame': '3 years', 'description': 'The investigators will calculate the area under the receiver operating characteristics curve (AUROC) for mortality as predicted by Artificial Intelligence technology'}, {'measure': 'Morbidity', 'timeFrame': 'baseline', 'description': '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)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Artificial Intelligence', 'Machine Learning', 'Electrocardiogram', 'convolutional neural network'], 'conditions': ['Pulmonary Hypertension (Diagnosis)']}, 'descriptionModule': {'briefSummary': "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:\n\n1. Can AI technology in the 12-lead ECG accurately predict the presence of PH?\n2. Can AI technology in the 12-lead ECG identify specific sub-types of PH?\n3. Can AI technology in the 12-lead ECG predict mortality in patients with PH?\n\nIn 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.", 'detailedDescription': "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.\n\nThis 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.\n\nFor 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients, aged 18 or over, who have a clinical suspicion of Pulmonary Hypertension and undergo Right Heart Catheterisation within 12 months of an ECG.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. 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.\n2. 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.\n\nExclusion Criteria:\n\n* Patient's less than 18 years-old\n* Patients who do not give valid consent (except deceased patients; REC approved)\n* Patients who have not undergone RHC to assess for PH\n* Patients who have not had an ECG within 12 months of their RHC"}, 'identificationModule': {'nctId': 'NCT05942859', 'briefTitle': 'Applying Artificial Intelligence to the 12 Lead ECG for the Diagnosis of Pulmonary Hypertension: an Observational Study', 'organization': {'class': 'OTHER', 'fullName': 'Royal United Hospitals Bath NHS Foundation Trust'}, 'officialTitle': 'Applying Artificial Intelligence to the 12 Lead ECG for the Diagnosis of Pulmonary Hypertension: an Observational Study', 'orgStudyIdInfo': {'id': 'RD2651'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Retrospective Cohort', 'description': '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.', 'interventionNames': ['Diagnostic Test: Artificial Intelligence and Machine Learning technology']}, {'label': 'Prospective Cohort', 'description': '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.', 'interventionNames': ['Diagnostic Test: Artificial Intelligence and Machine Learning technology']}], 'interventions': [{'name': 'Artificial Intelligence and Machine Learning technology', 'type': 'DIAGNOSTIC_TEST', 'description': "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.", 'armGroupLabels': ['Prospective Cohort', 'Retrospective Cohort']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bath', 'country': 'United Kingdom', 'facility': 'Royal United Hospital Bath NHS Trust', 'geoPoint': {'lat': 51.3751, 'lon': -2.36172}}], 'overallOfficials': [{'name': 'Dan Augustine, BSc, MBBS, MRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal United Bath NHS Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal United Hospitals Bath NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Liverpool John Moores University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}