Bronx Transthyretin Amyloid Cardiomyopathy Database

Active, not recruiting

• Conditions: Transthyretin Amyloid Cardiomyopathy; Transthyretin Cardiac Amyloidosis
• Interventions: Diagnostic Test: 99mTc-pyrophosphate Single Photon Emission Computed Tomography

• Registration Number: NCT06257485
• Lead Sponsor: Montefiore Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-23
• Study First Submitted: 2024-02-05
• Study First Submitted QC: 2024-02-12
• Study First Posted: 2024-02-14
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-24
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 476

Inclusion Criteria

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

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Exclusion Criteria

• Did not have a transthoracic echocardiogram in our medical records

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients referred for 99mTc-pyrophosphate Single Photon Emission Computed Tomography	99mTc-pyrophosphate Single Photon Emission Computed Tomography	Patients with suspected transthyretin cardiac amyloidosis referred for 99mTc-pyrophosphate Single Photon Emission Computed Tomography

Primary Outcome Measures

Name	Time	Method
ATTR-CM Diagnosis	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
Mortality	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 Outcome Measures

Name	Time	Method
Heart failure hospitalizations	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
Total Hospitalizations	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

Trial Locations

Locations (1)

Montefiore Health System; 🇺🇸 Bronx, New York, United States