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NCT06469372Completed

Cardiac Amyloidosis Discovery Trial

Source: ClinicalTrials.gov · Last updated 4 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
50 (actual)
First submitted
17 Jun 2024
Start date
28 May 2024
Primary completion date
1 Aug 2025
Lead sponsor
Pierre Elias
Diseases
Amyloidosis
NCT number
NCT06469372

What you commit to

  • Study type: Interventional
  • Participants enrolled: 50
  • From 28 May 2024 to the primary completion date, 1 Aug 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior liver or heart transplantation.
  • Previous testing for cardiac amyloidosis such as amyloid nuclear scintigraphy, cardiac, or fat pad biopsy.

Other illness

  • Active malignancy or non-amyloid disease with expected survival of less than 1 year.
  • Impairment from stroke, injury or other medical disorder that precludes participation in the study.
  • Disabling dementia or other mental or behavioral disease

Other

  • Primary amyloidosis (AL) or secondary amyloidosis (AA).
  • Nursing home resident.

Who the study is looking for

  • 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.

Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Columbia University Irving Medical Center / NewYork-Presbyterian Hospital
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.