Completed

Computer Algorithm for Early Cardiac Amyloidosis Detection

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Study Aim

This study aims to test a computer algorithm that helps doctors detect early signs of cardiac amyloidosis in patients, focusing on how often the condition is correctly diagnosed using the model.

What is being tested

Cardiac amyloidosis deep learning model

Device
Who is being recruted

Amyloidosis+12

+ Metabolic Diseases

+ Metabolism, Inborn Errors

Over 50 Years
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: May 2024
See protocol details

Summary

Principal SponsorPierre Elias
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 28, 2024

Actual date on which the first participant was enrolled.

Heart failure is a major health problem, and one of its causes is a condition called transthyretin cardiac amyloidosis (ATTR-CA), where abnormal proteins build up in the heart. This study focuses on identifying patients with this condition before it becomes severe, using a computer algorithm. The goal is to locate patients who may have cardiac amyloidosis but haven't been diagnosed yet. By diagnosing the condition early, it may be possible to provide better treatment and improve outcomes for those affected. This study targets patients at the Columbia University Irving Medical Center to find those with a high likelihood of having cardiac amyloidosis. Participants identified by the algorithm will undergo further testing to confirm the presence of cardiac amyloidosis. The diagnostic process involves sophisticated imaging tests like a SPECT scan to check for protein deposits in the heart and additional tests to rule out other types of amyloidosis. Some patients may need a biopsy, where a small tissue sample is taken to check for the protein buildup. The study measures success by accurately identifying patients who have the condition, to ensure timely and appropriate treatment. Although the study doesn't directly provide treatment, it plays a crucial role in catching the disease early, which can be beneficial for managing symptoms and improving quality of life.

Official TitleCardiac Amyloidosis Discovery Trial
NCT06469372
Principal SponsorPierre Elias
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AmyloidosisMetabolic DiseasesMetabolism, Inborn ErrorsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNervous System DiseasesNeuromuscular DiseasesNutritional and Metabolic DiseasesPeripheral Nervous System DiseasesAmyloid NeuropathiesNeurodegenerative DiseasesHeredodegenerative Disorders, Nervous SystemAmyloidosis, FamilialAmyloid Neuropathies, FamilialGenetic Diseases, InbornProteostasis Deficiencies

Criteria

Inclusion Criteria: * High predicted probability of having cardiac amyloidosis as determined by deep learning model. * Age ≥ 50 years. * Electronically stored ECG and echocardiogram within 5 years of study start date. * Ability for the patient or health care proxy to understand and sign the informed consent after the study has been explained. Exclusion Criteria: * Primary amyloidosis (AL) or secondary amyloidosis (AA). * Prior liver or heart transplantation. * Active malignancy or non-amyloid disease with expected survival of less than 1 year. * Previous testing for cardiac amyloidosis such as amyloid nuclear scintigraphy, cardiac, or fat pad biopsy. * Impairment from stroke, injury or other medical disorder that precludes participation in the study. * Disabling dementia or other mental or behavioral disease * Nursing home resident.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients who are identified by the deep learning model as being at high risk for undiagnosed cardiac amyloidosis who are enrolled in the study.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Columbia University Irving Medical Center / NewYork-Presbyterian Hospital

New York, United StatesOpen Columbia University Irving Medical Center / NewYork-Presbyterian Hospital in Google Maps
CompletedOne Study Center