Early Detection of Concealed Cardiac Amyloidosis Using AI-ECG and CT-Derived Extracellular Volume in Patients With Atrial Fibrillation (SEARCH-AF)
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.
Обзор исследования
Статус
Подробное описание
This study is a prospective randomized trial designed to evaluate the clinical utility of non-invasive early screening for cardiac amyloidosis (CA) using AI-ECG and CT-ECV in patients with atrial fibrillation (AF). The study primarily targets patients presenting with "red-flag" signs, such as heart failure symptoms, ECG findings of low voltage or pseudo-infarction, Troponin T > 0.03 ng/L, NT-proBNP > 332 pg/mL, LV wall thickness > 12 mm, a history of carpal tunnel syndrome or spinal canal stenosis, or proteinuria (e.g., UACR ≥ 300 mg/g, 24-hour proteinuria ≥ 0.5-1.0 g/day, or nephrotic-range proteinuria > 3.5 g/day).
The objective is to assess whether early screening improves the detection rate of CA and whether such early detection and subsequent treatment can improve clinical outcomes for patients. Subjects who meet the inclusion and exclusion criteria and provide informed consent will be randomly assigned to either the Early Screening Group or the Usual Care Group in a 1:1 ratio for comparative analysis. Participants will be allocated using stratified block randomization (allocation ratio 1:1) with a computer-generated random number sequence. Stratification variables, including age (age ≥ 75 vs. < 75 years) and sex.
Upon enrollment, all patients will undergo a baseline evaluation encompassing demographic information, medical history, and medication status, along with blood tests (e.g., NT-proBNP, troponin, creatinine). Additionally, AI-ECG analysis using standard 12-lead ECG or ECV analysis using cardiac CT will be performed. For AI-ECG analysis, the Mayo Clinic AI-ECG algorithm will be utilized; raw ECG data will be transmitted, and results will be received only for those patients who have provided specific consent. Patients who test positive in the AI-ECG analysis or cardiac CT-ECV analysis will undergo further diagnostic workup, including SPEP, UPEP, IFE, Free Light Chain Assay, and 99mTc-DPD scintigraphy. For those who test positive in these subsequent evaluations, definitive diagnosis will be attempted through endomyocardial biopsy or genetic testing.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Ju Youn Kim, Ph.D
- Номер телефона: 82+ 10-5482-7307
- Электронная почта: kzzoo921@gmail.com
Места учебы
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Seoul
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Seoul, Seoul, Южная Корея, 06351
- Samsung Medical Center
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Контакт:
- Ju Youn Kim, Ph.D
- Номер телефона: 82+ 2-3410-3419
- Электронная почта: kzzoo921@gmail.com
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Контакт:
- Ju hee Lee, RN
- Номер телефона: 82+ 2-2148-7611
- Электронная почта: phacyde12@gmail.com
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Скрининг
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Early screening group
AI-ECG and/or CT ECV analysis with standard atrial fibrillation treatment
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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.
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.
Standard care and treatment in accordance with established AF guidelines.
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Активный компаратор: Usual care group
Standard atrial fibrillation treatment
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Standard care and treatment in accordance with established AF guidelines.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Cardiac amyloidosis(CA) detection rate
Временное ограничение: From enrollment to the 2 year follow-up
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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.
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From enrollment to the 2 year follow-up
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Diagnostic Sensitivity and Specificity of AI-ECG alone, CT-ECV alone, and the combined Model
Временное ограничение: From enrollment to 2 year follow-up
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Compare the diagnostic sensitivity and specificity of each model, the difference in proportions between groups will be analyzed as a primary analysis using the chi-squared test or Fisher's exact test.
Furthermore, since the sensitivity and specificity of the AI-ECG, CT-ECV, and combined models are paired indicators derived from the same subjects, the McNemar test will be used for the comparison of sensitivity and specificity between models.
In cases where it is necessary to adjust for covariates (e.g., age, sex, NT-proBNP) or to consider repeated measures/correlation structures, a logistic regression analysis based on Generalized Estimating Equations (GEE) with subject IDs as clusters will be performed to compare model effects.
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From enrollment to 2 year follow-up
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Correlation of AI-ECG/CT-ECV values with other screening results in patients with confirmed CA
Временное ограничение: From enrollment to 2 year follow-up
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In patients with a confirmed CA, the association between AI-ECG scores/probabilities, CT-ECV (continuous), and clinical findings-such as biopsy results (if available), degree of DPD uptake (e.g., grade), and SPEP/UPEP/IFE results (positive/negative or quantitative values)-will be evaluated using Spearman correlation analysis and, if necessary, logistic or linear regression analysis.
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From enrollment to 2 year follow-up
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Соавторы и исследователи
Спонсор
Соавторы
Публикации и полезные ссылки
Общие публикации
- 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.
- 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.
- 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.
- 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.
- 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.
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Заболевания нервной системы
- Сердечно-сосудистые заболевания
- Патологические процессы
- Сердечные заболевания
- Нервно-мышечные заболевания
- Метаболизм, врожденные ошибки
- Генетические заболевания, врожденные
- Метаболические заболевания
- Заболевания периферической нервной системы
- Аритмии, Сердечные
- Нейродегенеративные заболевания
- Наследственные дегенеративные заболевания, нервная система
- Недостатки протеостаза
- Амилоидные невропатии
- Амилоидоз, семейный
- Врожденные, наследственные и неонатальные заболевания и аномалии
- Патологические состояния, признаки и симптомы
- Пищевые и метаболические заболевания
- Мерцательная аритмия
- Амилоидоз
- Амилоидные невропатии, семейные
Другие идентификационные номера исследования
- SMC 2025-12-132
- KCT0009027 (Другой идентификатор: Korea National Institute of Health)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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