ClinicalTrials.gov record NCT07567508

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Age19 years old and older
SexAll
LocationSouth Korea
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This randomized study compares an early screening approach using AI-enhanced ECG and CT-derived extracellular volume (CT-ECV) versus usual care in people with atrial fibrillation who have one or more ‘red-flag’ signs that may suggest cardiac amyloidosis. Participants are assigned 1:1 to either early screening plus standard AF treatment or standard AF treatment alone, and are followed for two years. Positive screening results trigger further diagnostic testing and attempts at definitive diagnosis.

What it is studying. Whether adding AI-ECG and/or CT-ECV screening to usual care changes the detection rate of cardiac amyloidosis, and how well each test (alone and combined) identifies cases and correlates with confirmatory tests and clinical findings.

What the researchers hope to learn. To determine whether non-invasive AI-ECG and CT-ECV screening increases detection of cardiac amyloidosis, to measure diagnostic accuracy (sensitivity/specificity) of each method and the combined model, and to evaluate how screening results relate to confirmatory tests and clinical outcomes.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Diagnostic test
  • AI-ECG analysis
  • CT-ECV analysis
Other
  • Atrial fibrillation treatment

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

After consent and a baseline evaluation (medical history and blood tests such as NT‑proBNP, troponin, creatinine), participants are randomized 1:1 to an early screening arm or usual-care arm and followed for 2 years. Early-screening participants may have AI‑ECG and/or cardiac CT for CT‑ECV; AI‑ECG raw data are transmitted only if the participant gives specific consent. If a screening test is positive, participants may undergo further diagnostic tests (SPEP, UPEP, immunofixation, free light chain assay, and 99mTc‑DPD scintigraphy) and, when indicated, attempts at definitive diagnosis by endomyocardial biopsy or genetic testing.

How the study is structured. An interventional, randomized (1:1), parallel-group trial with no masking. Eligible participants with AF and specified “red-flag” signs are randomized into an Early Screening group (AI-ECG and/or CT-ECV plus standard atrial fibrillation treatment) or a Usual Care group (standard atrial fibrillation treatment alone). Randomization uses stratified block allocation by age (≥75 vs <75) and sex. Participants have a baseline evaluation with blood tests and ECG/CT screening as applicable; those with positive screens undergo further diagnostic workup (blood and urine protein studies, scintigraphy) and, if indicated, confirmatory testing such as endomyocardial biopsy or genetic testing. All participants are followed for outcomes for two years.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Atrial Fibrillation (AF); Cardiac Amyloidosis. Does it apply to my diagnosis?
  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in South Korea. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on wild-type ATTR amyloidosis

This trial is also listed on this site under ATTRv amyloidosis.

Clinical trials121 trials listed for wild-type ATTR amyloidosisEvery trial the registry lists for wild-type ATTR amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in wild-type ATTR amyloidosis researchLatest monthly update: September 2026. Includes: Frailty and support needs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
May 2026 (estimated)
Primary completion
Dec 31, 2029 (estimated)
Study completion
Dec 31, 2029 (estimated)
Target enrollment
500 participants (estimated)
Last updated on registry
May 5, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Samsung Medical Center
Principal investigator
Ju Youn Kim, Professor
Samsung Medical Center
Collaborators
  • Mayo Clinic

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

ECG
A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
CT
An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
randomized
Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
1:1
How many participants go to each group. In a 2:1 ratio, two are assigned to the first group for every one assigned to the second.
usual care
Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.
written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
life expectancy
Some studies require that, in the investigator's judgement, a participant is likely to live long enough to complete the study period. It is a study requirement, not a prediction about any individual.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
stratified
Randomisation done separately within subgroups, such as age bands or disease severity, so that each group contains a similar mix.
allocation
How participants are assigned to study groups, for example at random or by a non-random rule.
enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
Free Light Chain
Small pieces of antibody protein made by plasma cells and measured in a blood test. In some conditions, such as AL amyloidosis, abnormal free light chains are the source of the disease.
biopsy
Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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