The Bronx-Valve Registry

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Valvular Heart Disease

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Race - American Indian or Alaska Native<br>Being identified as American Indian or Alaska Native | |
| Race - Asian<br>Being identified as Asian | |
| Race - Black or African-American<br>Being identified as Black or African-American | |
| Race - Native Hawaiian or Other Pacific Islander<br>Being identified as Native Hawaiian or Other Pacific Islander | |
| Race - White<br>Being identified as White | |
| Ethnicity - Spanish/Hispanic/Latino<br>Being identified as Spanish/Hispanic/Latino | |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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valvular heart disease, race, ethnicity, diversity, mitral valve, aortic valve, tricuspid valve, pulmonary valve, stenosis, regurgitation, echocardiography