Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Transthyretin Cardiac Amyloidosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, France, Germany, Spain, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis (CONCERTO)
Overview
CONCERTO is a retrospective, observational, multicentric and single-arm study to perform an external validation of the cloud-based and AI-powered electrocardiogram (ECG) analysis platform, named Willem™, to detect Transthyretin cardiac amyloidosis (ATTR-CA). Thus, this study will assess Willem™ ability to distinguish between truly diagnosed ATTR-CA patients and confirmed non-ATTR-CA patients from ECG data.
Detailed description
Transthyretin cardiac amyloidosis (ATTR-CA) is an infiltrative cardiomyopathy affecting cardiac health. Results from clinical trials have shown the importance of early diagnosis to improve outcomes and maximize treatment efficacy.
An electrocardiogram (ECG) is the most commonly performed cardiac diagnostic procedure, providing a large amount of information that can reflect cardiac structure and physiology. In this regard, ECG could be an ideal screening tool for ATTR-CA given its wide use, non-invasive nature, low cost and high sensitivity to reflect ATTR-CA abnormalities.
The CE-marked Willem™ ECG Analysis platform has already shown its capability to process ECG data to detect cardiac patterns and arrythmias. This retrospective, observational, multicentric and single-arm study aims to expand the capabilities of the Willem™ ECG Analysis platform, in this case to detect ATTR-CA from ECG analysis.
Primary outcome measures
- Device performance [Time frame: Baseline (closest clinical assessment to ATTR-CA diagnosis)]
Secondary outcome measures (1)
- Device performance with sub-optimal ECG data quality [Time frame: Baseline (closest clinical assessment to ATTR-CA diagnosis)]
Eligibility criteria
Inclusion criteria
- Subjects ≥ 18 years old
- Subjects with 12-leads ECG records with a 10 seconds minimum length on digital format
Exclusion criteria
- Patients with paced rhythm on the ECG.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Spain · 3 centers
- Hospital Universitario Son Llàtzer — Palma de Mallorca
- Hospital Universitario Donostia — San Sebastián
- Hospital Universitario Juan Ramón Jiménez — Huelva
Germany · 2 centers
- Universitätsklinikum Bonn — Bonn
- TUM Klinikum Deutsches Herzzentrum — München
United States · 1 center
- Northwestern University — Evanston
France · 1 center
- Centre Hospitalier Universitaire de Toulouse — Toulouse
United Kingdom · 1 center
- Queen Elizabeth University Hospital, Univeisity of Glasgow — Glasgow
Identifiers
NCT: NCT06978660 · CON_1b