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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorSamsung Medical Center

About this trial

This study investigates the clinical efficacy of a non-invasive screening protocol using AI-ECG and CT-ECV analysis for cardiac amyloidosis. The study targets on atrial fibrillation(AF) patients with "red-flag" indicators.

Participants are randomized 1:1 into either an early screening or usual care group.

* Early screening group : AI- ECG and/or CT-ECV analysis + AF treatment * Usual care group : AF treatment Both groups followed for 2 years to compare CA detection rates and clinical outcomes.

Eligibility criteria

Qualifiers

Adults aged 19 or older who have provided voluntary written informed consent.

Patients with a history of AF (paroxysmal or persistent) and one or more red-flag symptoms/signs.

Patients who can undergo at least one of the following: AI-ECG analysis or CT-ECV analysis.

Disqualifiers

Patients previously diagnosed with cardiac amyloidosis (AL or ATTR).

Patients with severe heart failure (NYHA class IV) or terminal illness with a life expectancy of less than 1 year.

Patients deemed inappropriate for participation by the investigator.

Trial design

Treatments tested in this trial

  • AI-ECG analysis
  • CT-ECV analysis
  • Atrial fibrillation treatment

Treatment groups

500 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Samsung Medical Center

Lead sponsor

Mayo Clinic

Collaborator