The Bronx-Valve Registry

Valvular Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05453526
• Other study ID #: 2022-13933
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: August 2024

Study information

• Verified date: March 2024
• Source: Montefiore Medical Center
• Contact: Andrea Scotti, MD
• Phone: 718-904-3388
• Email: ascotti[@]montefiore.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330571
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Diseases
• Heart Valve Diseases
• Valvular Heart Disease

Locations

Country	Name	City	State
United States	Montefiore Medical Center	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	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
Primary	Prevalence of Valvular Heart Disease	Prevalence of each valvular heart disease will be compared among pre-defined racial/ethnical groups	Up to 10 years
Primary	All-cause mortality	All-cause mortality according to valvular heart disease and racial/ethnical group	Up to 10 years