Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2026-01-12 @ 9:13 PM
Study NCT ID:
NCT06168968
Status:
RECRUITING
Last Update Posted:
2024-11-05
First Post:
2023-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multidisciplinary Approach to Reduce Cardiovascular Health Disparities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-01', 'studyFirstSubmitDate': '2023-12-05', 'studyFirstSubmitQcDate': '2023-12-05', 'lastUpdatePostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in Platelet Fibrin Clot Formation (MA,mm)', 'timeFrame': 'Baseline', 'description': 'Differences in Platelet Fibrin Clot Formation (MA,mm) Between Black and White Patients'}, {'measure': 'Differences in Speed of Clot Formation (R, min)', 'timeFrame': 'Baseline', 'description': 'Differences in Speed of Clot Formation (R, min) Between Black and White Patients'}], 'secondaryOutcomes': [{'measure': 'Major Adverse Cardiovascular Events Post Index Hospitalization', 'timeFrame': '3 and 12 months post index hospitalization', 'description': 'Major Adverse Cardiovascular Events (death, MI, stroke, unplanned target vessel revascularization, major bleeding) Post Index Hospitalization'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Coronary Syndrome', 'Multi Vessel Coronary Artery Disease', 'Ischemic Stroke']}, 'descriptionModule': {'briefSummary': '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.\n\nParticipants will engage in laboratory testing and health outcome assessments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Two Cohorts (Cohort 1 = Secondary Prevention, Cohort 2 = Primary Prevention)\n\n\\- See information about specific Cohorts', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ≥18 years of age admitted with ACS, AIS, or multi-vessel CAD\n* Competent mental condition to provide informed consent and able to participate in follow-ups\n\nExclusion Criteria:\n\n* Pregnant women\n* Currently enrolled in an investigational drug or device trial\n* Undergoing treatment for neoplastic, autoimmune, or connective tissue disease\n* COVID-19 infection within 30 days of enrollment\n* Known history of hepatitis or HIV\n* Deemed unfit to participate according to the investigator\n* Known history of drug abuse\n* Known platelet count of \\<100,000/mm3\n* Hematocrit \\< 25%'}, 'identificationModule': {'nctId': 'NCT06168968', 'acronym': 'M-BRACE', 'briefTitle': 'Multidisciplinary Approach to Reduce Cardiovascular Health Disparities', 'organization': {'class': 'OTHER', 'fullName': 'LifeBridge Health'}, 'officialTitle': 'Multidisciplinary Approach to Reduce Cardiovascular Health Disparities in the Baltimore RAcial Minority CommunitiEs (M-BRACE Trial)', 'orgStudyIdInfo': {'id': '1941089'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient', 'description': '(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', 'interventionNames': ['Behavioral: Life and Medication Recommendations']}, {'label': 'Family Member', 'description': '(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', 'interventionNames': ['Behavioral: Life and Medication Recommendations']}], 'interventions': [{'name': 'Life and Medication Recommendations', 'type': 'BEHAVIORAL', 'description': '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', 'armGroupLabels': ['Family Member', 'Patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21215', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Paul Gurbel, MD', 'role': 'CONTACT', 'email': 'pgurbel@lifebridgehealth.org', 'phone': '410-591-2473'}, {'name': 'Kevin Bliden, MBA', 'role': 'CONTACT', 'email': 'kbliden@lifebridgehealth.org', 'phone': '443-244-1497'}, {'name': 'Paul Gurbel, MD', 'role': 'CONTACT'}], 'facility': 'Sinai Hospital of Baltimore', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'centralContacts': [{'name': 'Kevin Bliden, BS, MBA', 'role': 'CONTACT', 'email': 'kbliden@lifebridgehealth.org', 'phone': '4432441497'}], 'overallOfficials': [{'name': 'Jenna Brager, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'LifeBridge Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LifeBridge Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Maryland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Cardiovascular Research', 'investigatorFullName': 'Paul A. Gurbel', 'investigatorAffiliation': 'LifeBridge Health'}}}}