RECRUITING

Cardiac Amyloidosis Discovery Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Cardiac Amyloidosis Discovery Trial

Quick Facts

Study Start:2024-05-28
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06469372

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.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * High predicted probability of having cardiac amyloidosis as determined by deep learning model.
  2. * Age ≥ 50 years.
  3. * Electronically stored ECG and echocardiogram within 5 years of study start date.
  4. * Ability for the patient or health care proxy to understand and sign the informed consent after the study has been explained.
  1. * Primary amyloidosis (AL) or secondary amyloidosis (AA).
  2. * Prior liver or heart transplantation.
  3. * Active malignancy or non-amyloid disease with expected survival of less than 1 year.
  4. * Previous testing for cardiac amyloidosis such as amyloid nuclear scintigraphy, cardiac, or fat pad biopsy.
  5. * Impairment from stroke, injury or other medical disorder that precludes participation in the study.
  6. * Disabling dementia or other mental or behavioral disease
  7. * Nursing home resident.

Contacts and Locations

Study Contact

Timothy J. Poterucha, MD
CONTACT
(212) 932-4537
tp2558@cumc.columbia.edu

Principal Investigator

Timothy J. Poterucha, MD
PRINCIPAL_INVESTIGATOR
Assistant Professor of Medicine

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Pierre Elias

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

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

Study Start Date2024-05-28
Study Completion Date2025-12

Study Record Updates

Study Start Date2024-05-28
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Cardiac Amyloidosis
  • Artificial Intelligence
  • Deep Learning

Additional Relevant MeSH Terms

  • Cardiac Amyloidosis