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Cardiac Amyloidosis Discovery Trial

NCT06469372 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-04

Study results available
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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.

Conditions

  • Cardiac Amyloidosis

Interventions

DEVICE

Cardiac amyloidosis deep learning model

This is a deep learning algorithm which intakes a patient's age, sex, clinical factors known to be related to amyloidosis and their ECG and echocardiogram results and determines their estimated risk for having cardiac amyloidosis.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • American Heart Association

    collaborator OTHER

  • Eidos Therapeutics, a BridgeBio company

    collaborator INDUSTRY

  • Pierre Elias

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-28
Primary Completion
2025-08-01
Completion
2025-08-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06469372 on ClinicalTrials.gov