CONCERTO-UK
Research type
Research Study
Full title
Multicenter study for the validation of an AI-based ECG platform for early cardiac amyloidosis diagnosis (CONCERTO-UK)
IRAS ID
362054
Contact name
Manuel Marina Breysse
Contact email
Sponsor organisation
IDOVEN 1903, S.L.
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Transthyretin cardiac amyloidosis (ATTR) is caused by protein build-up in the heart. New drugs are available which can slow the disease. Starting these treatments early can improve outcomes for patients. However, patients often receive a diagnosis years after they start experiencing symptoms.
Many patients receive a heart trace (ECG) in hospital. ECGs can provide information about the heart, including signs of ATTR. Screening ECGs could find more people who might benefit from ATTR treatment.
CONCERTO is a study which will use ECGs to test and develop an artificial intelligence (AI) computer programme. The aim is to find out if the computer programme can detect ATTR from ECGs.
No new ECGs will be collected for this research. We will use tests patients have had previously. All identifiable information (like names or CHIs) will be removed from patient data before being used.
For this study, we will:
1) use ECGs from patients who have been diagnosed with ATTR and those who have tested negative for the disease
2) we will then use this data to improve the computer programme, by letting it ‘learn’ the right answers
3) We will test the computer programme on examples it has not seen before. This includes ECGs from a broad variety of patients, including patients with:
- ATTR or likely ATTR
- other diseases caused by abnormal proteins
- patients tested for heart failure
- the general population
- patients who carry a gene for ATTR but have not developed symptoms.This is to better understand how the computer programme might work if it was used by doctors in the future.
Parts 1 and 2 are being carried out different countries around the world, to make sure that the computer programme works well for everyone. Part 3 will only take place in Glasgow, using Scottish data.
REC name
South East Scotland REC 02
REC reference
26/SS/0037
Date of REC Opinion
20 Mar 2026
REC opinion
Favourable Opinion