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

NCT07567508 | Not Yet Recruiting

• 2 other identifiers: SMC 2025-12-132KCT0009027
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

AI-ECG; Amyloidosis; Cardiac amyloidosis; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Cardiac amyloidosis(CA) detection rate

  CA detection rate in the early screening group based on AI-ECG and CT-ECV results The superiority hypothesis (detection rate of the early screening group \> control group) will be tested, utilizing the chi-squared test or Fisher's exact test as the primary analysis. Effect sizes will be reported as the difference in proportions, odds ratio (OR), and relative risk (RR), along with 95% CIs and p-values.

  From enrollment to the 2 year follow-up

Secondary Outcomes (2)

• Diagnostic Sensitivity and Specificity of AI-ECG alone, CT-ECV alone, and the combined Model

  From enrollment to 2 year follow-up

• Correlation of AI-ECG/CT-ECV values with other screening results in patients with confirmed CA

  From enrollment to 2 year follow-up

Study Arms (2)

Early screening group

EXPERIMENTAL

AI-ECG and/or CT ECV analysis with standard atrial fibrillation treatment

Diagnostic Test: AI-ECG analysis; Diagnostic Test: CT-ECV analysis; Other: Atrial fibrillation treatment

Usual care group

ACTIVE COMPARATOR

Standard atrial fibrillation treatment

Other: Atrial fibrillation treatment

Interventions

AI-ECG analysis DIAGNOSTIC_TEST

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.

Early screening group

CT-ECV analysis DIAGNOSTIC_TEST

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.

Early screening group

Atrial fibrillation treatment OTHER

Standard care and treatment in accordance with established AF guidelines.

Early screening group; Usual care group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead
• Mayo Clinic: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, Seoul, 06351, South Korea

Location

Related Publications (5)

• Oguni T, Takashio S, Kuyama N, Hirakawa K, Hanatani S, Oike F, Usuku H, Matsuzawa Y, Kidoh M, Oda S, Yamamoto E, Ueda M, Hirai T, Tsujita K. Clinical characteristics of patients with high extracellular volume fraction evaluated by cardiac computed tomography for coronary artery evaluation. Eur Heart J Open. 2024 Apr 27;4(3):oeae036. doi: 10.1093/ehjopen/oeae036. eCollection 2024 May.

  PMID: 38751455 RESULT

• Shinzato K, Takahashi Y, Yamaguchi T, Otsubo T, Nakashima K, Yoshioka G, Yokoi K, Tsuruta K, Osako R, Shichida S, Nishimura Y, Edayoshi M, Kawano Y, Shintani-Domoto Y, Miyazaki K, Fukui A, Kawaguchi A, Aoki S, Nomura S, Takahashi N, Ito K, Node K. Atrial amyloidosis identified by biopsy in atrial fibrillation: prevalence and clinical presentation. Eur Heart J. 2025 Sep 15;46(35):3437-3449. doi: 10.1093/eurheartj/ehaf332.

  PMID: 40392565 RESULT

• Yamasaki H, Kondo H, Shiroo T, Iwata N, Masuda T, Makita T, Iwabuchi Y, Tanazawa K, Takahashi M, Ono Y, Ogawa N, Harada T, Mitarai K, Yamauchi S, Takano M, Kodama N, Hirota K, Miyoshi M, Yonezu K, Tawara K, Abe I, Saito S, Fukui A, Fukuda T, Akioka H, Shinohara T, Akiyoshi K, Teshima Y, Yufu K, Daa T, Matsubara E, Asayama Y, Ueda M, Takahashi N. Efficacy of Computed Tomography-Based Evaluation of Myocardial Extracellular Volume Combined With Red Flags for Early Screening of Concealed Cardiac Amyloidosis in Patients With Atrial Fibrillation. Circ J. 2024 Jun 25;88(7):1167-1175. doi: 10.1253/circj.CJ-23-0948. Epub 2024 Mar 22.

  PMID: 38522901 RESULT

• Harmon DM, Mangold K, Suarez AB, Scott CG, Murphree DH, Malik A, Attia ZI, Lopez-Jimenez F, Friedman PA, Dispenzieri A, Grogan M. Postdevelopment Performance and Validation of the Artificial Intelligence-Enhanced Electrocardiogram for Detection of Cardiac Amyloidosis. JACC Adv. 2023 Oct;2(8):100612. doi: 10.1016/j.jacadv.2023.100612. Epub 2023 Sep 14.

  PMID: 38638999 RESULT

• Garcia-Pavia P, Rapezzi C, Adler Y, Arad M, Basso C, Brucato A, Burazor I, Caforio ALP, Damy T, Eriksson U, Fontana M, Gillmore JD, Gonzalez-Lopez E, Grogan M, Heymans S, Imazio M, Kindermann I, Kristen AV, Maurer MS, Merlini G, Pantazis A, Pankuweit S, Rigopoulos AG, Linhart A. Diagnosis and treatment of cardiac amyloidosis: a position statement of the ESC Working Group on Myocardial and Pericardial Diseases. Eur Heart J. 2021 Apr 21;42(16):1554-1568. doi: 10.1093/eurheartj/ehab072.

  PMID: 33825853 RESULT

MeSH Terms

Conditions

Atrial Fibrillation; Amyloid Neuropathies, Familial; Amyloidosis

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Proteostasis Deficiencies

Central Study Contacts

Ju Youn Kim, Ph.D

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 5, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-02

Locations

KR (1)