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

NCT07567508 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-05-05

No results posted yet for this study

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.

Conditions

  • Atrial Fibrillation (AF)
  • Cardiac Amyloidosis

Interventions

DIAGNOSTIC_TEST

AI-ECG analysis

Artificial Intelligence-enhanced Electrocardiogram (AI-ECG), developed by Mayo Clinic, is gaining attention as a non-invasive screening tool. AI-ECG predicts myocardial amyloid deposition based on a standard 12-lead ECG with high accuracy, AUC 0.84(95% CI 0.82-0.86) In particular, it demonstrated superior performance with an AUC of 0.9 or higher in ECGs exhibiting low voltage or pseudo-infarction patterns, suggesting its potential to detect the disease even before structural changes become apparent.

DIAGNOSTIC_TEST

CT-ECV analysis

Myocardial Extracellular Volume (CT-ECV) analysis using cardiac CT is a tissue characterization technique that can be easily added to conventional cardiac CT protocols, enabling the quantification of myocardial fibrosis or infiltrative diseases. Among 874 subjects who underwent coronary CT, 12.4% exhibited a CT-ECV of ≥ 35%, and cardiac amyloidosis was incidentally discovered in 14.3% of these individuals.

OTHER

Atrial fibrillation treatment

Standard care and treatment in accordance with established AF guidelines.

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • Samsung Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2029-12-31
Completion
2029-12-31

Countries

  • South Korea

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07567508 on ClinicalTrials.gov