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Clinical Trials/NCT06168968
NCT06168968
Recruiting
N/A

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

LifeBridge Health1 site in 1 country400 target enrollmentFebruary 6, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Acute Coronary Syndrome
Sponsor
LifeBridge Health
Enrollment
400
Locations
1
Primary Endpoint
Differences in Platelet Fibrin Clot Formation (MA,mm)
Status
Recruiting
Last Updated
last year

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
February 6, 2023
End Date
December 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Paul A. Gurbel

Director of Cardiovascular Research

LifeBridge Health

Eligibility Criteria

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%

Outcomes

Primary Outcomes

Differences in Platelet Fibrin Clot Formation (MA,mm)

Time Frame: Baseline

Differences in Platelet Fibrin Clot Formation (MA,mm) Between Black and White Patients

Differences in Speed of Clot Formation (R, min)

Time Frame: Baseline

Differences in Speed of Clot Formation (R, min) Between Black and White Patients

Secondary Outcomes

  • Major Adverse Cardiovascular Events Post Index Hospitalization(3 and 12 months post index hospitalization)

Study Sites (1)

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