Multidisciplinary Approach to Reduce Cardiovascular Health Disparities (M-BRACE)

November 1, 2024 updated by: Paul A. Gurbel, LifeBridge Health

Multidisciplinary Approach to Reduce Cardiovascular Health Disparities in the Baltimore RAcial Minority CommunitiEs (M-BRACE Trial)

The goal of this observational study is to investigate the potential differences in thrombogenicity between black and white patients admitted with atherothrombotic events including acute coronary syndrome, multi-vessel coronary disease, and ischemic stroke.

Participants will engage in laboratory testing and health outcome assessments.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

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

Study Contact

Study Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Two Cohorts (Cohort 1 = Secondary Prevention, Cohort 2 = Primary Prevention)

- See information about specific Cohorts

Description

Inclusion Criteria:

  • Patients ≥18 years of age admitted with ACS, AIS, or multi-vessel CAD
  • Competent mental condition to provide informed consent and able to participate in follow-ups

Exclusion Criteria:

  • Pregnant women
  • Currently enrolled in an investigational drug or device trial
  • Undergoing treatment for neoplastic, autoimmune, or connective tissue disease
  • COVID-19 infection within 30 days of enrollment
  • Known history of hepatitis or HIV
  • Deemed unfit to participate according to the investigator
  • Known history of drug abuse
  • Known platelet count of <100,000/mm3
  • Hematocrit < 25%

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient
(Secondary Prevention) Includes black (n=150) and white (n=150) patients greater than or equal to 18 years of age hospitalized for acute coronary syndrome (ACS), multi-vessel disease, or ischemic stroke undergoing intervention
Behavioral: Life and Medication Recommendations
Based on obtained subjective and objective data from patient-filled questionnaire and laboratory testing respectively, lifestyle and medication recommendations will be provided for secondary prevention of cardiovascular and cerebrovascular diseases
Family Member
(Primary Prevention) Includes black subjects (n=75) who are first or second-degree relatives of patients in Cohort 1 and have no history of prior hospitalization for cardiovascular or cerebrovascular disease
Behavioral: Life and Medication Recommendations
Based on obtained subjective and objective data from patient-filled questionnaire and laboratory testing respectively, lifestyle and medication recommendations will be provided for secondary prevention of cardiovascular and cerebrovascular diseases

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in Platelet Fibrin Clot Formation (MA,mm)
Time Frame: Baseline
Differences in Platelet Fibrin Clot Formation (MA,mm) Between Black and White Patients
Baseline
Differences in Speed of Clot Formation (R, min)
Time Frame: Baseline
Differences in Speed of Clot Formation (R, min) Between Black and White Patients
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiovascular Events Post Index Hospitalization
Time Frame: 3 and 12 months post index hospitalization
Major Adverse Cardiovascular Events (death, MI, stroke, unplanned target vessel revascularization, major bleeding) Post Index Hospitalization
3 and 12 months post index hospitalization

Collaborators and Investigators

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

Sponsor

LifeBridge Health

Collaborators

University of Maryland

Investigators

  • Study Chair: Jenna Brager, PhD, LifeBridge Health

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)

February 6, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

December 5, 2023

First Submitted That Met QC Criteria

December 5, 2023

First Posted (Actual)

December 13, 2023

Study Record Updates

Last Update Posted (Estimated)

November 5, 2024

Last Update Submitted That Met QC Criteria

November 1, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1941089

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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