NCT04724200Completed
Optimising a Digital Diagnostic Pathway for Heart Failure in the Community
Source: ClinicalTrials.gov · Last updated 28 Mar 2024
Brief summary (registry, in English)
This is a prospective, observational study. The primary aim is to assess the diagnostic accuracy of Artificial Intelligence (AI) analysis of Point of Care (POC) handheld transthoracic echocardiogram images (POC handheld echocardiogram) compared to the current gold-standard of transthoracic echocardiogram images acquired and analysed by a British Society of Echocardiography (BSE) accredited operator, using a standard echocardiogram machine (standard TTE), for the diagnosis of Heart Failure with reduced Ejection Fraction (HFrEF), in patients referred from the community for investigation of suspected new Heart Failure (HF).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 867 (actual)
- First submitted
- 5 Jan 2021
- Start date
- 5 Jan 2021
- Primary completion date
- 27 Aug 2021
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Diseases
- Heart failure
- NCT number
- NCT04724200
What you commit to
- Study type: Observational
- Participants enrolled: 867
- From 5 Jan 2021 to the primary completion date, 27 Aug 2021
- 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.
Prior treatment
- Individuals with a previous ICD-10 diagnosis of HF in any coding position
Other illness
- Inability of the participant, in the opinion of the investigators, to understand and/or comply with study procedures, or any conditions that, in the opinion of the investigators, may render the participant unable to understand, attend and/or undergo study visit investigations
Age
- Individuals less than 18 years of age
Other
- Individuals who have had an interim echocardiogram for another clinical reason, whilst on the outpatient echocardiogram waiting list for investigation of HF
- Inability to read and understand the PIS (provided in English only), and understand the research team
Who the study is looking for
- Adult individuals referred from the community who are awaiting HF diagnostic investigations, including echocardiography, to investigate for a suspected new diagnosis of HF
Age in the registry: 18 years to - · Sex: All · Does not accept 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 |
|---|---|---|---|
| NHS Louisa Jordan Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.