Computer Algorithm for Early Cardiac Amyloidosis Detection
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.
Cardiac amyloidosis deep learning model
Amyloidosis+12
+ Metabolic Diseases
+ Metabolism, Inborn Errors
Diagnostic Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Diagnostic Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy 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
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
New York, United StatesOpen Columbia University Irving Medical Center / NewYork-Presbyterian Hospital in Google Maps