NCT05942859Enrolling by invitation
Applying Artificial Intelligence to the 12 Lead ECG for the Diagnosis of Pulmonary Hypertension: an Observational Study
Source: ClinicalTrials.gov · Last updated 5 Oct 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 600 (estimated)
- First submitted
- 4 Jul 2023
- Start date
- Oct 2023
- Primary completion date
- Aug 2024
- Lead sponsor
- Royal United Hospitals Bath NHS Foundation Trust
- NCT number
- NCT05942859
What you commit to
- Study type: Observational
- Planned participants: 600
- From Oct 2023 to the primary completion date, Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Royal United Hospital Bath NHS Trust Coordinator of this site? Confirm its status | Bath | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.