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

StatusEnrolling by Invitation
PhaseNot specified
Started2023-10
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 5, 2023 (before its estimated August 2024 completion). Its status may not reflect the trial's current state.

Amendment history

2023-10-04
minor
Study Status v1
Primary completion date2024-07→2024-08
Completion date2027-07→2027-08
Start date2023-07→2023-10
2023-07-04
minor
Original filing
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.
Trial Details
NCT Number NCT05942859
Lead Sponsor Royal United Hospitals Bath NHS Foundation Trust
Collaborators: Liverpool John Moores University
Conditions Pulmonary Hypertension (Diagnosis)
Enrollment 600 participants
Start Date 2023-10
Primary Completion 2024-08 (estimated)
Study Completion 2027-08 (estimated)
Updated on ClinicalTrials.gov 2023-10-05