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Early Detection of Concealed Cardiac Amyloidosis Using AI-ECG and CT-Derived Extracellular Volume in Patients with Atrial Fibrillation

Early Detection of Concealed Cardiac Amyloidosis Using AI-ECG and CT-Derived Extracellular Volume in Patients with Atrial Fibrillation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0011652
Enrollment
500
Registered
2026-02-25
Start date
2026-03-04
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others(Early screening for cardiac amyloidosis via AI-ECG or CT-ECV) : The AI-enhanced electrocardiogram (AI-ECG) developed by Mayo Clinic is a tool that offers the potential for early, non-invasive s

Sponsors

Samsung Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Adults aged 19 years or older who have provided written informed consent (including consent from a legal representative in cases where voluntary consent is not feasible) 2) Patients with a documented history of atrial fibrillation (paroxysmal or persistent) and the presence of at least one "red-flag" symptom or sign. 3) Patients capable of undergoing at least one of the following diagnostic assessments: ? AI-ECG analysis based on standard 12-lead electrocardiogram data. ? Extracellular Volume (ECV) analysis derived from cardiac CT imaging.

Exclusion criteria

Exclusion criteria: 1) Patients with a prior diagnosis of cardiac amyloidosis (either AL or ATTR type). 2) Patients with severe heart failure (NYHA class IV) or those with a terminal illness and a life expectancy of less than one year. 3) Any other condition or situation that the investigator deems inappropriate for participation in the study.

Design outcomes

Primary

MeasureTime frame
Cardiac amyloidosis detection rate

Secondary

MeasureTime frame
Diagnostic sensitivity and specificity of AI-ECG alone, CT-ECV alone, and the combined model;Correlation analysis between AI-ECG/CT-ECV indices and biopsy findings, 99mTc-DPD scintigraphy, and serum/urine monoclonal protein assays in patients with confirmed cardiac amyloidosis

Countries

Korea, Republic of

Contacts

Public ContactJuyoun Kim

Samsung Medical Center

kzzoo921@gmail.com+82-2-3410-3419

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Mar 14, 2026