Multidisciplinary Approach to Reduce Cardiovascular Health Disparities

NCT06168968 | Unknown

• 1 other identifier: 1941089
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome; Multi Vessel Coronary Artery Disease; Ischemic Stroke

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Major Adverse Cardiovascular Events Post Index Hospitalization

  3 and 12 months post index hospitalization

Study Arms (2)

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

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

Interventions

Life and Medication Recommendations BEHAVIORAL

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; Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Two Cohorts (Cohort 1 = Secondary Prevention, Cohort 2 = Primary Prevention) \- See information about specific Cohorts

You may qualify if:

• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• LifeBridge Health: lead
• University of Maryland: collaborator

Study Sites (1)

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome; Ischemic Stroke

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jenna Brager, PhD

  LifeBridge Health

  STUDY CHAIR

Central Study Contacts

Kevin Bliden, BS, MBA

CONTACT

4432441497; kbliden@lifebridgehealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiovascular Research

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 13, 2023
• Study Start: February 6, 2023
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 5, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)