Multidisciplinary Approach to Reduce Cardiovascular Health Disparities

NCT ID: NCT06168968

Last Updated: 2024-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-06

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Acute Coronary Syndrome Multi Vessel Coronary Artery Disease Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Life and Medication Recommendations

Intervention Type 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

(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

Life and Medication Recommendations

Intervention Type 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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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%
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Maryland

OTHER

Sponsor Role collaborator

LifeBridge Health

OTHER

Sponsor Role lead

Responsible Party

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Paul A. Gurbel

Director of Cardiovascular Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jenna Brager, PhD

Role: STUDY_CHAIR

LifeBridge Health

Locations

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Sinai Hospital of Baltimore

Baltimore, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kevin Bliden, BS, MBA

Role: CONTACT

4432441497

Facility Contacts

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Paul Gurbel, MD

Role: primary

410-591-2473

Kevin Bliden, MBA

Role: backup

443-244-1497

Paul Gurbel, MD

Role: backup

Other Identifiers

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1941089

Identifier Type: -

Identifier Source: org_study_id

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