Bronx Transthyretin Amyloid Cardiomyopathy Database

NCT06257485 | Active Not Recruiting

• 1 other identifier: 2023-15264
• Study Type: observational
• Target: 476
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Transthyretin Cardiac Amyloidosis; Transthyretin Amyloid Cardiomyopathy

Keywords

transthyretin cardiac amyloidosis; transthyretin amyloid cardiomyopathy

Outcome Measures

Primary Outcomes (2)

• ATTR-CM Diagnosis

  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

  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 Outcomes (2)

• Heart failure hospitalizations

  Within the study time frame parameters of the retrospective review (between 2014 and 2023)

• Total Hospitalizations

  Within the study time frame parameters of the retrospective review (between 2014 and 2023)

Study Arms (1)

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

Interventions

99mTc-pyrophosphate Single Photon Emission Computed Tomography DIAGNOSTIC_TEST

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

Patients referred for 99mTc-pyrophosphate Single Photon Emission Computed Tomography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Did not have a transthoracic echocardiogram in our medical records

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Health System

The Bronx, New York, 10467, United States

Location

Related Links

• Performance of Clinical Scoring Systems in the Diagnosis of Transthyretin Amyloid Cardiomyopathy in a Diverse Patient Cohort

Study Officials

• Leandro Slipczuk, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 14, 2024
• Study Start: September 23, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)