Bronx Transthyretin Amyloid Cardiomyopathy Database

January 7, 2026 updated by: Montefiore Medical Center

Database of Transthyretin Amyloid Cardiomyopathy Cases in a Racially and Ethnically Diverse Population in the Bronx

Transthyretin amyloid cardiomyopathy (ATTR-CM) is a commonly undiagnosed and potentially fatal disease. Contemporary studies on this condition often underrepresent the female gender and diverse patient populations. This registry retrospectively evaluated patients referred for 99mTc-pyrophosphate (PYP) Single Photon Emission Computed Tomography (SPECT) between 2014 and 2023 at Montefiore-Einstein in the Bronx. The patient population is racially and ethnically diverse and with a high proportion of females. Demographic, clinical (e.g. comorbidities), laboratory, echocardiographic, hospitalization, and mortality data were collected for each patient.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

476

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • The Bronx, New York, United States, 10467
        • Montefiore Health System

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All adult patients referred for PYP SPECT at Montefiore Medical Center between 2014 and 2023 who had a transthoracic echocardiogram in our medical records.

Description

Inclusion Criteria:

  • All adult patients referred for PYP SPECT at Montefiore Medical Center between 2014 and 2023

Exclusion Criteria:

  • Did not have a transthoracic echocardiogram in our medical records

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients referred for 99mTc-pyrophosphate Single Photon Emission Computed Tomography
Patients with suspected transthyretin cardiac amyloidosis referred for 99mTc-pyrophosphate Single Photon Emission Computed Tomography
Diagnostic test: 99mTc-pyrophosphate Single Photon Emission Computed Tomography
All patients underwent 99mTc-pyrophosphate Single Photon Emission Computed Tomography and had a baseline echocardiogram

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ATTR-CM Diagnosis
Time Frame: During the index PYP scan within the study time frame parameters of the retrospective review (between 2014 and 2023)
The number of patients who underwent a PYP SPECT scan diagnostic of ATTR-CM will be assessed and reported
During the index PYP scan within the study time frame parameters of the retrospective review (between 2014 and 2023)
Mortality
Time Frame: Within the study time frame parameters of the retrospective review (between 2014 and 2023)
The number of patients who died from all-cause mortality will be tabulated and reported
Within the study time frame parameters of the retrospective review (between 2014 and 2023)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart failure hospitalizations
Time Frame: Within the study time frame parameters of the retrospective review (between 2014 and 2023)
The number of patients admitted to the hospital with a primary diagnosis of heart failure will be tabulated and reported
Within the study time frame parameters of the retrospective review (between 2014 and 2023)
Total Hospitalizations
Time Frame: Within the study time frame parameters of the retrospective review (between 2014 and 2023)
The number of patients admitted to the hospital with any diagnosis will be tabulated and reported
Within the study time frame parameters of the retrospective review (between 2014 and 2023)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Investigators

  • Principal Investigator: Leandro Slipczuk, MD, Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

September 23, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 5, 2024

First Submitted That Met QC Criteria

February 12, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-15264

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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