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

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: Ischemic Stroke; Acute Coronary Syndrome; Multi Vessel Coronary Artery Disease
• Intervention / Treatment: Behavioral: Life and Medication Recommendations

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Kevin Bliden, BS, MBA; Phone Number: 4432441497; Email: kbliden@lifebridgehealth.org

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Recruiting
      • Sinai Hospital of Baltimore
      • Contact: Paul Gurbel, MD; Phone Number: 410-591-2473; Email: pgurbel@lifebridgehealth.org
      • Contact: Kevin Bliden, MBA; Phone Number: 443-244-1497; Email: kbliden@lifebridgehealth.org
      • Contact: Paul Gurbel, MD

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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)	Differences in Platelet Fibrin Clot Formation (MA,mm) Between Black and White Patients	Baseline
Differences in Speed of Clot Formation (R, min)	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	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

• Sponsor: LifeBridge Health
• Collaborators: University of Maryland
• Investigators: Study Chair: Jenna Brager, PhD, LifeBridge Health

Study record dates

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: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Stroke; Ischemic Stroke; Coronary Artery Disease; Acute Coronary Syndrome
• 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