Cardiac Amyloidosis Discovery Trial

Description

This is a single center, diagnostic clinical trial in which the investigators aim to prospectively validate a deep learning model that identifies patients with features suggestive of cardiac amyloidosis, including transthyretin cardiac amyloidosis (ATTR-CA). Cardiac Amyloidosis is an age-related infiltrative cardiomyopathy that causes heart failure and death that is frequently unrecognized and underdiagnosed. The investigators have developed a deep learning model that identifies patients with features of ATTR-CA and other types of cardiac amyloidosis using echocardiographic, ECG, and clinical factors. By applying this model to the population served by NewYork-Presbyterian Hospital, the investigators will identify a list of patients at highest predicted risk for having undiagnosed cardiac amyloidosis. The investigators will then invite these patients for further testing to diagnose cardiac amyloidosis. The rate of cardiac amyloidosis diagnosis of patients in this study will be compared to rate of cardiac amyloidosis diagnosis in historic controls from the following two groups: (1) patients referred for clinical cardiac amyloidosis testing at NewYork-Prebysterian Hospital and (2) patients enrolled in the Screening for Cardiac Amyloidosis With Nuclear Imaging in Minority Populations (SCAN-MP) study.

Conditions

Cardiac Amyloidosis

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Study Overview

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Study Details

Study overview

This is a single center, diagnostic clinical trial in which the investigators aim to prospectively validate a deep learning model that identifies patients with features suggestive of cardiac amyloidosis, including transthyretin cardiac amyloidosis (ATTR-CA). Cardiac Amyloidosis is an age-related infiltrative cardiomyopathy that causes heart failure and death that is frequently unrecognized and underdiagnosed. The investigators have developed a deep learning model that identifies patients with features of ATTR-CA and other types of cardiac amyloidosis using echocardiographic, ECG, and clinical factors. By applying this model to the population served by NewYork-Presbyterian Hospital, the investigators will identify a list of patients at highest predicted risk for having undiagnosed cardiac amyloidosis. The investigators will then invite these patients for further testing to diagnose cardiac amyloidosis. The rate of cardiac amyloidosis diagnosis of patients in this study will be compared to rate of cardiac amyloidosis diagnosis in historic controls from the following two groups: (1) patients referred for clinical cardiac amyloidosis testing at NewYork-Prebysterian Hospital and (2) patients enrolled in the Screening for Cardiac Amyloidosis With Nuclear Imaging in Minority Populations (SCAN-MP) study.

Cardiac Amyloidosis Discovery Trial

Cardiac Amyloidosis Discovery Trial

Condition
Cardiac Amyloidosis
Intervention / Treatment

-

Contacts and Locations

New York

Columbia University Irving Medical Center / NewYork-Presbyterian Hospital, New York, New York, United States, 10032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

50 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Pierre Elias,

Timothy J. Poterucha, MD, PRINCIPAL_INVESTIGATOR, Assistant Professor of Medicine

Study Record Dates

2025-12