NCT05453526

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330,570

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 12, 2022

Completed
Last Updated

February 3, 2025

Status Verified

January 1, 2025

Enrollment Period

10 years

First QC Date

July 1, 2022

Last Update Submit

January 30, 2025

Conditions

Keywords

valvular heart diseaseraceethnicitydiversitymitral valveaortic valvetricuspid valvepulmonary valvestenosisregurgitationechocardiography

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (6)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Related Publications (2)

  • Echarte-Morales J, Scotti A, Bonnet G, Torrado J, Sturla M, Coisne A, Ludwig S, Barzallo D, Escabia C, Chandra A, Kodesh A, Aftab A, Granada JF, Ho EC, Jorde UP, Rodriguez CJ, Slipczuk L, Garcia MJ, Latib A. Racial and ethnic disparities in patients with severe tricuspid regurgitation: The Bronx-Valve registry. Int J Cardiol. 2025 Feb 15;421:132889. doi: 10.1016/j.ijcard.2024.132889. Epub 2024 Dec 6.

  • Scotti A, Sturla M, Echarte-Morales J, Ho EC, Millin A, Coisne A, Ludwig S, Leone PP, Rosiene J, Granada JF, Goldberg Y, Pu M, Jorde UP, Slipczuk L, Rodriguez CJ, Garcia MJ, Latib A. Burden of Valvular Heart Diseases in a Racially and Ethnically Diverse Population: The Bronx-Valve Registry. J Am Heart Assoc. 2025 Jan 21;14(2):e035378. doi: 10.1161/JAHA.124.035378. Epub 2025 Jan 16.

MeSH Terms

Conditions

Heart Valve DiseasesConstriction, PathologicGastroesophageal Reflux

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Azeem Latib, MD

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2022

First Posted

July 12, 2022

Study Start

January 1, 2010

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

February 3, 2025

Record last verified: 2025-01

Locations