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OpenTrials
Active, Not Recruiting

NCT Number: NCT06257485

Bronx Transthyretin Amyloid Cardiomyopathy Database

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Transthyretin Cardiac Amyloidosis Transthyretin Amyloid Cardiomyopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Montefiore Health System

The Bronx, New York, 10467, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

99mTc-pyrophosphate Single Photon Emission Computed Tomography

Diagnostic Test

All patients underwent 99mTc-pyrophosphate Single Photon Emission Computed Tomography and had a baseline echocardiogram

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 14, 2024
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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