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NCT06168968 Clinical Trial

Multidisciplinary Approach to Reduce Cardiovascular Health Disparities

Acute Coronary Syndrome Clinical Trial

— M-BRACE  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06168968
Other study ID # 1941089
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 6, 2023
Est. completion date August 2025

Study information
Verified date December 2023
Source LifeBridge Health
Contact Kevin Bliden, BS, MBA
Phone 4432441497
Email kbliden@lifebridgehealth.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date August 2025
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

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

Locations
Country Name City State
United States Sinai Hospital of Baltimore Baltimore Maryland

Sponsors (2)
Lead Sponsor Collaborator
LifeBridge Health University of Maryland

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Differences in Platelet Fibrin Clot Formation (MA,mm) Differences in Platelet Fibrin Clot Formation (MA,mm) Between Black and White Patients Baseline
Primary Differences in Speed of Clot Formation (R, min) Differences in Speed of Clot Formation (R, min) Between Black and White Patients Baseline
Secondary 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
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