Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-01-02 @ 11:05 PM
Study NCT ID:
NCT05403151
Status:
RECRUITING
Last Update Posted:
2025-10-06
First Post:
2022-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Controls and Healthy Vasculature Initiative
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10-02', 'completionDateStruct': {'date': '2032-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-03', 'studyFirstSubmitDate': '2022-06-02', 'studyFirstSubmitQcDate': '2022-06-02', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To collect samples from healthy volunteers to establish and validate technical assays and normal physiologic mechanisms and parameters for on-going and future basic and translational research studies.', 'timeFrame': 'Up to 10 Years', 'description': 'This protocol does not have an outcome measure, but will obtain blood samples to optimize assays, conduct mechanistic investigations, measure vascular biomarkers, and facilitate the study of vascular and immunologic diseases in patients enrolled in other studies.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sample Collection', 'Vascular', 'Blood', 'Inflammation', 'Thrombosis', 'Natural History'], 'conditions': ['Vascular And Immunologic Diseases', 'Healthy Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_000829-H.html', 'label': 'NIH Clinical Center Detailed Web Page'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nDiseases involving blood, blood vessels, and immune systems are leading causes of death in the United States. Researchers studying these diseases need to compare blood samples from both healthy and sick individuals. Blood samples from healthy people are also used to establish what is normal when developing new tests for diseases and to make sure new testing equipment is working properly.\n\nObjective:\n\nThis natural history study will collect blood samples from healthy people. The blood will be used for various kinds of research.\n\nEligibility:\n\nHealthy adults aged 18 years or older. Pregnant or nursing women will be excluded.\n\nDesign:\n\nParticipants will have a telehealth visit or telephone call to review their medical history.\n\nThey will come to the NIH Clinical Center. They will have a needle inserted into a vein in their arm or hand. About 10 tablespoons of blood will be drawn through the needle.\n\nResearchers may perform a complete blood count, a type of blood test that can help evaluate the participant s overall health. They may do a blood type test.\n\nThe blood samples will also be used for genetic studies.\n\nSome blood samples may be stored for use in future research.\n\nParticipants may choose to return for repeat visits for up to 10 years. Review of their medical history may also be repeated at later visits. They will receive $50 per blood collection visit.\n\n...', 'detailedDescription': 'Study Description:\n\nThis study will serve to provide tissue samples from individuals with healthy vasculature for mechanistic studies of vascular inflammation and thrombosis.\n\nObjectives:\n\nPrimary Objective:\n\nTo collect samples from healthy volunteers to:\n\n* Establish and validate technical assays and equipment (e.g. platelet aggregation, inflammasome activation, neutrophil extracellular trap formation, tissue factor activity, etc.)\n* Establish normal physiologic mechanisms and parameters in samples from healthy volunteers (e.g. platelet function, circulating autoantibody titers, etc.)\n\nEndpoints:\n\nThis protocol does not have an outcome measure, but rather will be conducted in accordance with Good Clinical Practices for human research solely for the purpose of obtaining blood samples to optimize assays, conduct mechanistic investigations, measure vascular biomarkers, and facilitate the study of vascular and immunologic diseases in patients enrolled in other studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy Volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Stated willingness to comply with all study procedures\n* Aged 18 years and older\n* Ability of subject to understand and the willingness to sign a written informed consent document\n* Self-reported in good general health\n\nEXCLUSION CRITERIA:\n\nAn individual who, by self-report, meets the following criteria will be excluded from participation in this study:\n\n-Current pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT05403151', 'briefTitle': 'Controls and Healthy Vasculature Initiative', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Controls and Healthy Vasculature Initiative', 'orgStudyIdInfo': {'id': '10000829'}, 'secondaryIdInfos': [{'id': '000829-H'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Healthy Adults'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sandra Cooper Bennett, M.S.N.', 'role': 'CONTACT', 'email': 'sandra.cooper@nih.gov', 'phone': '240-328-0465'}, {'name': 'Yogendra Kanthi, M.D.', 'role': 'CONTACT', 'email': 'yogen.kanthi@nih.gov'}], 'facility': 'National Institutes of Health Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'centralContacts': [{'name': 'Sandra Cooper Bennett, R.N.', 'role': 'CONTACT', 'email': 'sandra.cooper@nih.gov', 'phone': '(240) 328-0465'}], 'overallOfficials': [{'name': 'Yogendra Kanthi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Heart, Lung, and Blood Institute (NHLBI)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}