Multidisciplinary Approach to Reduce Cardiovascular Health Disparities

Recruiting

• Conditions: Acute Coronary Syndrome; Ischemic Stroke; Multi Vessel Coronary Artery Disease
• Interventions: Behavioral: Life and Medication Recommendations

• Registration Number: NCT06168968
• Lead Sponsor: LifeBridge Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-06
• Status Verified: 2023-12
• Study First Submitted: 2023-12-05
• Study First Submitted QC: 2023-12-05
• Study First Posted: 2023-12-13
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-05
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 2	Life and Medication Recommendations	(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
Cohort 1	Life and Medication Recommendations	(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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Major Adverse Cardiovascular Events Post Index Hospitalization	3 and 12 months post index hospitalization	Major Adverse Cardiovascular Events (death, MI, stroke, unplanned target vessel revascularization, major bleeding) Post Index Hospitalization

Trial Locations

Locations (1)

Sinai Hospital of Baltimore; 🇺🇸 Baltimore, Maryland, United States