Not Yet RecruitingNot Applicable

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

South Korea500 participantsStarted 2026-05

Plain-language summary

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.

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cardiac amyloidosis(CA) detection rate

Timeframe: From enrollment to the 2 year follow-up

Trial details

NCT IDNCT07567508

SponsorSamsung Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-12-31

Contact for this trial

Ju Youn Kim, Ph.D

82+ 10-5482-7307 kzzoo921@gmail.com

View on ClinicalTrials.gov More Atrial Fibrillation (AF) trials