Acute Coronary SyndromeM-BRACENCT06168968
Multidisciplinary Approach to Reduce Cardiovascular Health Disparities
An observational study of Acute Coronary Syndrome and Multi Vessel Coronary Artery Disease, run by LifeBridge Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Multi Vessel Coronary Artery Disease, Ischemic Stroke
- What is being tested?
- Life and Medication Recommendations
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2023to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Two Cohorts (Cohort 1 = Secondary Prevention, Cohort 2 = Primary Prevention) - See information about specific Cohorts
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Known history of drug abuse
- Known platelet count of <100,000/mm3
- Hematocrit < 25%
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Paul Gurbel, MD, 410-591-2473, pgurbel@lifebridgehealth.org
Kevin Bliden, MBA, 443-244-1497, kbliden@lifebridgehealth.org
About this study
Official title: Multidisciplinary Approach to Reduce Cardiovascular Health Disparities in the Baltimore RAcial Minority CommunitiEs (M-BRACE Trial)
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.
- Being tested
- Life and Medication Recommendations
- Medical subject headings
- Acute Coronary Syndrome, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Life and Medication RecommendationsBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Life and Medication Recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Platelet Fibrin Clot Formation (MA,mm)
Differences in Platelet Fibrin Clot Formation (MA,mm) Between Black and White Patients
Measured: Baseline
Differences in Speed of Clot Formation (R, min)
Differences in Speed of Clot Formation (R, min) Between Black and White Patients
Measured: Baseline
Secondary outcomes (1)
Major Adverse Cardiovascular Events Post Index Hospitalization
Major Adverse Cardiovascular Events (death, MI, stroke, unplanned target vessel revascularization, major bleeding) Post Index Hospitalization
Measured: 3 and 12 months post index hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start6 Feb 2023
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LifeBridge Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland
- Responsible party
- Principal investigator, Paul A. Gurbel, LifeBridge Health
- Investigators
- Jenna Brager, PhD, Study chair, LifeBridge Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168968
- Sponsor's protocol ID
- 1941089
- Acronym
- M-BRACE
- Status last verified
- Dec 2023
- First submitted
- 5 Dec 2023
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gurbel PA, Tantry US, Bliden KP, Ashley WW, Jeong YH, Tsimikas S. Lipoprotein(a), Oxidized Phospholipids and Tensile Clot Strength Measured by Thromboelastography in Patients Undergoing Percutaneous Intervention. Arterioscler Thromb Vasc Biol. 2026 Oct;46(10):e324402. doi: 10.1161/ATVBAHA.126.324402. Epub 2026 Aug 20.
PubMed 42619605
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidisciplinary Approach to Reduce Cardiovascular Health Disparities in the Baltimore RAcial Minority CommunitiEs (M-BRACE Trial)
- ClinicalTrials.gov ID
- NCT06168968
- Acronym / sponsor ID
- M-BRACE / 1941089
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- LifeBridge HealthUniversity, hospital or other
- Collaborators
- University of Maryland
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Behavioral: 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 |
| Family Member | – | Behavioral: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Two Cohorts (Cohort 1 = Secondary Prevention, Cohort 2 = Primary Prevention) - See information about specific Cohorts
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Life and Medication RecommendationsBased 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 | Behavioural | Family Member, Patient |
Primary outcome
Differences in Platelet Fibrin Clot Formation (MA,mm)
Time frame: Baseline
Differences in Platelet Fibrin Clot Formation (MA,mm) Between Black and White Patients
Differences in Speed of Clot Formation (R, min)
Time frame: Baseline
Differences in Speed of Clot Formation (R, min) Between Black and White Patients
1 secondary outcome
Major Adverse Cardiovascular Events Post Index Hospitalization
Time frame: 3 and 12 months post index hospitalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Derived from this study: PubMed 42619605Gurbel PA, Tantry US, Bliden KP, Ashley WW, Jeong YH, Tsimikas S. Lipoprotein(a), Oxidized Phospholipids and Tensile Clot Strength Measured by Thromboelastography in Patients Undergoing Percutaneous Intervention. Arterioscler Thromb Vasc Biol. 2026 Oct;46(10):e324402. doi: 10.1161/ATVBAHA.126.324402. Epub 2026 Aug 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jenna Brager, PhD study chair
LifeBridge Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Multi Vessel Coronary Artery Disease, run by LifeBridge Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kevin Bliden, BS, MBA (4432441497, kbliden@lifebridgehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in Platelet Fibrin Clot Formation (MA,mm) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06168968, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.