The Bronx-Valve Registry

Completed

• Conditions: Valvular Heart Disease

• Registration Number: NCT05453526
• Lead Sponsor: Montefiore Medical Center

Brief Summary

The Bronx-Valve Registry is designed to collect and assess data on all patients with valvular diseases referred to Montefiore Medical Center for echocardiographic exams. Valvular heart disease (VHD) is a major focus of cardiovascular medicine, but limited data are available for racial and ethnic minorities. The aim was to assess the burden and clinical correlates of VHD in a highly diverse area of the United States.

Detailed Description

Cardiovascular disease is the leading cause of death in the general US population. Although the burden of valvular heart disease is increasing due to a rapidly aging population, patients can benefit from improved and more accessible imaging modalities, and novel minimally invasive treatments. However, medical knowledge and technological developments might not be generalizable to all patient backgrounds due to lack of diversity in scientific literature.

Historically, clinical trials testing new treatment modalities have lacked equitable inclusion of people coming from racial/ethnic minority groups. Similarly, epidemiological studies have focused on specific patient subsets with no direct comparisons with the other backgrounds. The Bronx county (New York, USA) is considered by the US Census as the most diverse area in the country, having the highest overwhelming concentration of non-white populations and being the only borough in all of New York City to be almost exclusively populated by non-white enclaves. These demographic characteristics make this county ideal to assess how the prevalence and the clinical correlates of valvular heart diseases might vary among diverse populations.

On this background, the objective of this registry is to assess the burden of valvular heart diseases and explore their clinical correlates in the most diverse area of the United States.

Study Timeline

• Study Start: 2010-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Study First Submitted: 2022-07-01
• Study First Submitted QC: 2022-07-06
• Study First Posted: 2022-07-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330570

Inclusion Criteria

• Minimum age of 18 years old
• Undergoing transthoracic or transesophageal echocardiographic assessment at Montefiore Medical Center or affiliated institutions in the Bronx (NY, USA)

Exclusion Criteria

• Age below 18 years old
• No available information regarding race or ethnicity

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause mortality	Up to 10 years	All-cause mortality according to valvular heart disease and racial/ethnical group
Racial/ethnical based differences in baseline characteristics and valvular heart disease	Baseline	Baseline characteristics among pre-defined racial/ethnical groups will be compared for each valvular heart disease
Prevalence of Valvular Heart Disease	Up to 10 years	Prevalence of each valvular heart disease will be compared among pre-defined racial/ethnical groups

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States