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NCT07147725Not yet recruiting

Pulmonary Arterial Hypertension and Associated Cardiovascular Disease Detection Using Artificial Intelligence

Source: ClinicalTrials.gov · Last updated 23 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Cardiovascular disease (CVD) is a leading global cause of morbidity and mortality and excessive healthcare expenditures. Pulmonary hypertension (PH) represents an insidious and progressive subset of CVD affecting an estimated 1% of the general population, increasing to up to 10% in the population over the age of 65. Recent advancements in artificial intelligence (AI) have shown promise in transforming PH diagnosis by enabling the analysis of complex physiological data. Specifically, AI algorithms applied to electrocardiography (ECG) and phonocardiography (PCG) waveforms captured through novel medical devices, such as smart stethoscopes, have demonstrated potential in detecting PH and other cardiovascular conditions with high sensitivity and specificity. Despite the promising capabilities of AI algorithms, a significant barrier to their clinical implementation is the lack of high-quality, prospectively collected datasets for validation. Many existing AI algorithms have been trained on retrospective data, which may not capture the variability and complexity of real-world clinical scenarios. This limitation raises concerns about the generalisability and reliability of AI predictions across diverse patient populations. Therefore, there is a critical need for prospective validation studies to assess the performance of AI algorithms in realworld settings, ensuring their accuracy and applicability before widespread clinical deployment. Imperial College London's Health Impact Lab (Hi Lab) and collaborators continue to develop artificial intelligence (AI) algorithms that use cardiac waveforms to predict cardiovascular disease (CVD), including pulmonary hypertension (PH). The performance of these algorithms requires validation on prospectively collected patient data (waveforms) - where the ground truth for the algorithms under investigation is recorded during routine echocardiography as part of clinical care. This study aims to prospectively collect a large dataset of cardiovascular ECG and PCG data, along with corresponding gold-standard echocardiography findings. This dataset will be used to validate AI algorithms for important CVD, such as pulmonary hypertension enhancing their reliability and clinical applicability.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
1000 (estimated)
First submitted
22 Aug 2025
Start date
1 Oct 2025
Primary completion date
1 Dec 2025
Lead sponsor
Imperial College London
NCT number
NCT07147725

What you commit to

  • Study type: Observational
  • Planned participants: 1000
  • From 1 Oct 2025 to the primary completion date, 1 Dec 2025
  • 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

  • Any chest wound, skin pathology or other feature that would prohibit routine stethoscope examination

Who the study is looking for

  • Age 18 years or above
  • Able to give informed consent
  • Attending for echocardiography at Imperial College NHS Trust

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Imperial College Healthcare NHS Trust
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.