Multidisciplinary Approach to Reduce Cardiovascular Health Disparities

Study 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.

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

Conditions
-----------------
Acute Coronary Syndrome, Multi Vessel Coronary Artery Disease, Ischemic Stroke

Intervention / Treatment
-----------------
* Behavioral: Life and Medication Recommendations


Participation Criteria
=================
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%

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>(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<br>* 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<br>|
| Cohort 2<br>(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<br>* 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<br>|

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 |