Cardiac Amyloidosis Discovery Trial
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
🗓️ Study Start (Actual) 28 May 2024
🗓️ Primary Completion (Estimated) December 2025
✅ Study Completion (Estimated) December 2025
👥 Enrollment (Estimated) 100
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 50 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 17 June 2024
  • First Submitted that Met QC Criteria 17 June 2024
  • First Posted 21 June 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 17 June 2024
  • Last Update Posted 21 June 2024
  • Last Verified June 2024