Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-01-01 @ 5:49 AM
Study NCT ID:
NCT06552767
Status:
RECRUITING
Last Update Posted:
2025-10-02
First Post:
2024-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thrombosis and Inflammation in Vessels Initiative (TIVI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09-30', 'completionDateStruct': {'date': '2034-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-01', 'studyFirstSubmitDate': '2024-08-07', 'studyFirstSubmitQcDate': '2024-08-13', 'lastUpdatePostDateStruct': {'date': '2025-10-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2034-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'This is a disease discovery protocol and there are no specific endpoints associated with this protocol.', 'timeFrame': 'Study End'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vascular'], 'conditions': ['Cardiovascular Diseases', 'Vascular Diseases']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_001781-H.html', 'label': 'NIH Clinical Center Detailed Web Page'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nDiseases related to the immune system, blood clots, and blood vessels can affect every part of the body. These diseases are now known to be interrelated: People who have strokes, blood clots in their legs, or autoimmune disease, for example, are at greater risk of complications in the heart, brain, and other organs. Researchers want to learn more about how these diseases start, how they change over time, and how they affect different organs.\n\nObjective:\n\nTo learn more about how inflammation and diseases of the blood vessels start and how they change over time.\n\nEligibility:\n\nPeople aged 5 years and older with a disease related to blood clots, the immune system, or blood vessels. Healthy relatives of people with these diseases and unrelated healthy volunteers are also needed.\n\nDesign:\n\nParticipants will have a baseline visit: They will provide a medical history, physical exam and blood test. All other tests and procedures are optional; these may be spread over more than 1 day:\n\nTests of heart and lung function.\n\nFill in a family tree form.\n\nImaging scans\n\nTreadmill or bike stress tests and a 6-minute walk test.\n\nTests of blood pressure and the flow of blood through vessels.\n\nPhotos of the face and body.\n\nEye exams, with photos taken of the retina.\n\nSaliva and urine samples.\n\nBiopsies (tissues samples) of the skin and fat.\n\nTests of thinking and mental function.\n\nEvaluations by other medical specialists.\n\nParticipants may opt to return for repeat testing for up to 90 months (7.5 years).\n\nSome visits may be done by telehealth.', 'detailedDescription': 'Study Description:\n\nThrombotic vascular disorders remain the leading cause of morbidity and mortality in the United States. The proximate determinants of thrombosis, arterial, venous, and lymphatic vascular disorders and their treatments remains incompletely understood. In pursuit of improved vascular health, this disease discovery protocol will facilitate rapid initiation of new clinical and molecular phenotype-specific investigations to collect data and biospecimens on affected individuals, family members, and unrelated healthy controls. The data collected in this protocol will inform the design of future disease-specific investigational protocols.\n\nObjectives:\n\nPrimary Objective:\n\nTo study the pathogenesis of patients affected with thrombotic, immune, vascular, and cardiovascular conditions including clinical, radiographic, immunological and genetic characteristics of the disease.\n\nSecondary Objectives:\n\n* To develop long-term clinical and laboratory outcome parameters of organ involvement in patients with thrombotic, inflammatory, vascular and cardiovascular diseases\n* Evaluation of blood, body fluid, and tissue biomarkers during disease flares and quiescence.\n* To develop disease activity indices for vascular disease that incorporate clinical, laboratory, and imaging data.\n* Screening for other NHLBI clinical studies\n* To evaluate patients referred for suspected vascular disease and provide additional opinions for diagnosis and management recommendations\n\nEndpoints:\n\nThis is a disease discovery protocol and there are no specific endpoints associated with this protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '5 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with relevant immune, inflammation, thrombotic and/or vascular diseases and their relatives 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* Age \\>= 5 years at the time of consent\n* Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document\n\nIn addition, the following cohort-specific inclusion criteria apply:\n\nAffected Subjects:\n\n-Known or possible thrombotic, immune, or vascular disorder after review of the subject s medical records and/or discussion of medical history\n\nRelatives of Affected Subjects:\n\n-Being a relative of an affected subject\n\nUnrelated Healthy Controls:\n\n-In good general health as evidenced by medical history\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n-Any condition that in the opinion of the Investigator would warrant exclusion\n\nUnrelated Healthy Controls:\n\n* Unrelated healthy volunteers who decline to have blood drawn and/or tissue studies or who do not consent to have samples stored for future research\n* Cognitively impaired individuals'}, 'identificationModule': {'nctId': 'NCT06552767', 'briefTitle': 'Thrombosis and Inflammation in Vessels Initiative (TIVI)', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Thrombosis and Inflammation in Vessels Initiative (TIVI)', 'orgStudyIdInfo': {'id': '10001781'}, 'secondaryIdInfos': [{'id': '001781-H'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Affected Participants and Relatives', 'description': 'Participants with relevant immune, inflammation, thrombotic and/or vascular diseases and their relatives'}, {'label': 'Healthy Volunteers', 'description': 'Healthy volunteers'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Yogendra Kanthi, M.D.', 'role': 'CONTACT', 'email': 'yogen.kanthi@nih.gov', 'phone': '301-529-7297'}, {'name': 'Sandra Cooper Bennett, M.S.N.', 'role': 'CONTACT', 'email': 'sandra.cooper@nih.gov', 'phone': '(240) 328-0465'}], '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'}, {'name': 'Yogendra Kanthi, M.D.', 'role': 'CONTACT', 'email': 'yogen.kanthi@nih.gov', 'phone': '(301) 529-7297'}], 'overallOfficials': [{'name': 'Yogendra Kanthi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Heart, Lung, and Blood Institute (NHLBI)'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'Where appropriate, deidentified IPD will be made accessible as noted in the data management plan filed for this study.', 'ipdSharing': 'YES', 'description': 'Deidentified data from IPD or aggregated data may be shared in publications for scientific data reporting and interpretation.', 'accessCriteria': 'Where appropriate, deidentified IPD will be made accessible as noted in the data management plan filed for this study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}