The Bronx-Valve Registry

January 30, 2025 updated by: Montefiore Medical Center

Burden of Valvular Heart Diseases in an Ethnical/Racial Diverse Background of the United States: the Bronx-Valve Registry

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

330570

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All adult patients undergoing echocardiographic assessment at Montefiore Medical Center (Bronx, NY, USA) will be included in this registry.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Race - American Indian or Alaska Native
Being identified as American Indian or Alaska Native
Race - Asian
Being identified as Asian
Race - Black or African-American
Being identified as Black or African-American
Race - Native Hawaiian or Other Pacific Islander
Being identified as Native Hawaiian or Other Pacific Islander
Race - White
Being identified as White
Ethnicity - Spanish/Hispanic/Latino
Being identified as Spanish/Hispanic/Latino

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Investigators

  • Principal Investigator: Azeem Latib, MD, Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

July 1, 2022

First Submitted That Met QC Criteria

July 6, 2022

First Posted (Actual)

July 12, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 30, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-13933

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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