Cardiac Amyloidosis Discovery Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• 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.

Locations
United States
New York
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
RECRUITING
New York
Contact Information
Primary
Timothy J. Poterucha, MD
tp2558@cumc.columbia.edu
(212) 932-4537
Time Frame
Start Date: 2024-05-28
Estimated Completion Date: 2025-12
Participants
Target number of participants: 100
Treatments
Experimental: Intervention Arm
Patients who are identified by the deep learning model as being at high risk for undiagnosed cardiac amyloidosis who are enrolled in the study.
Sponsors
Collaborators: Pfizer, American Heart Association, Eidos Therapeutics, a BridgeBio company
Leads: Pierre Elias

This content was sourced from clinicaltrials.gov