Applying Artificial Intelligence to the 12 Lead ECG for the Diagnosis of Pulmonary Hypertension: an Observational Study
Study Purpose
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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
Yes |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Observational [Patient Registry] |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT05942859 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Royal United Hospitals Bath NHS Foundation Trust |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Dan Augustine, BSc, MBBS, MRCP |
Principal Investigator Affiliation | Royal United Bath NHS Foundation Trust |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
Overall Status | Enrolling by invitation |
Countries | United Kingdom |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Pulmonary Hypertension (Diagnosis) |
Contact a Trial Team
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