Recruiting

Cardiovascular Disparities

Sponsor:

LifeBridge Health

Code:

NCT06168968

Conditions

Acute Coronary Syndrome

Multi Vessel Coronary Artery Disease

Ischemic Stroke

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Life and Medication Recommendations

Study Details

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

Study ID

NCT06168968

Start date

Feb 6, 2023

Status verified date

Dec, 2023

Completion date

Dec, 2025

Anticipated

Primary completion date

Jun, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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

Interventions

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

Primary outcome measure

  • Differences in Platelet Fibrin Clot Formation (MA,mm) [ Time Frame: Baseline ]
  • Differences in Speed of Clot Formation (R, min) [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Kevin Bliden, BS, MBA

4432441497kbliden@lifebridgehealth.org

Locations

Sinai Hospital of Baltimore

Recruiting

Baltimore, Maryland, United States, 21215

Contacts

Paul Gurbel, MD

410-591-2473pgurbel@lifebridgehealth.org

Kevin Bliden, MBA

443-244-1497kbliden@lifebridgehealth.org

More Information

Sponsor

LifeBridge Health

Last update posted

Nov 5, 2024

Last verified

Dec, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by LifeBridge Health on 2024-11-05.