Bronx Transthyretin Amyloid Cardiomyopathy Database

Transthyretin Amyloid Cardiomyopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06257485
• Other study ID #: 2023-15264
• Status: Active, not recruiting
• Start date: September 23, 2023
• Est. completion date: October 2024

Study information

• Verified date: April 2024
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 476
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyloidosis
• Cardiomyopathies
• Transthyretin Amyloid Cardiomyopathy
• Transthyretin Cardiac Amyloidosis

Intervention

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

Locations

Country	Name	City	State
United States	Montefiore Health System	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Heart failure hospitalizations	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)
Secondary	Total Hospitalizations	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)