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The Bronx-Valve Registry

Montefiore Medicine Academic Health System logo

Montefiore Medicine Academic Health System

Status

Completed

Conditions

Valvular Heart Disease

Study type

Observational

Funder types

Other

Identifiers

NCT05453526
2022-13933

Details and patient eligibility

About

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.

Full 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.

Enrollment

330,570 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

330,570 participants in 6 patient groups

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

Trial contacts and locations

1

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Central trial contact

Andrea Scotti, MD; Azeem Latib, MD

Data sourced from clinicaltrials.gov

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