Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-30 @ 3:04 AM
Study NCT ID:
NCT00005356
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel Hemostatic Cardiac Risk Factors in Framingham
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D016757', 'term': 'Death, Sudden, Cardiac'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D002340', 'term': 'Carotid Artery Diseases'}], 'ancestors': [{'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D003645', 'term': 'Death, Sudden'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'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'}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1994-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-03', 'completionDateStruct': {'date': '1998-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-17', 'studyFirstSubmitDate': '2000-05-25', 'studyFirstSubmitQcDate': '2000-05-25', 'lastUpdatePostDateStruct': {'date': '2016-02-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2000-05-26', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases', 'Heart Diseases', 'Death, Sudden, Cardiac', 'Myocardial Infarction', 'Thrombosis', 'Atherosclerosis', 'Carotid Artery Diseases']}, 'referencesModule': {'references': [{'pmid': '9054738', 'type': 'BACKGROUND', 'citation': 'Welty FK, Mittleman MA, Wilson PW, Sutherland PA, Matheney TH, Lipinska I, Muller JE, Levy D, Tofler GH. Hypobetalipoproteinemia is associated with low levels of hemostatic risk factors in the Framingham offspring population. Circulation. 1997 Feb 18;95(4):825-30. doi: 10.1161/01.cir.95.4.825.'}, {'pmid': '8724556', 'type': 'BACKGROUND', 'citation': 'Rosito GB, Tofler GH. Hemostatic factors as triggers of cardiovascular events. Cardiol Clin. 1996 May;14(2):239-50. doi: 10.1016/s0733-8651(05)70277-0.'}, {'pmid': '10645922', 'type': 'BACKGROUND', 'citation': "Poli KA, Tofler GH, Larson MG, Evans JC, Sutherland PA, Lipinska I, Mittleman MA, Muller JE, D'Agostino RB, Wilson PW, Levy D. Association of blood pressure with fibrinolytic potential in the Framingham offspring population. Circulation. 2000 Jan 25;101(3):264-9. doi: 10.1161/01.cir.101.3.264."}, {'pmid': '10634338', 'type': 'BACKGROUND', 'citation': "Meigs JB, Mittleman MA, Nathan DM, Tofler GH, Singer DE, Murphy-Sheehy PM, Lipinska I, D'Agostino RB, Wilson PW. Hyperinsulinemia, hyperglycemia, and impaired hemostasis: the Framingham Offspring Study. JAMA. 2000 Jan 12;283(2):221-8. doi: 10.1001/jama.283.2.221."}, {'pmid': '7895352', 'type': 'BACKGROUND', 'citation': 'Gebara OC, Mittleman MA, Sutherland P, Lipinska I, Matheney T, Xu P, Welty FK, Wilson PW, Levy D, Muller JE, et al. Association between increased estrogen status and increased fibrinolytic potential in the Framingham Offspring Study. Circulation. 1995 Apr 1;91(7):1952-8. doi: 10.1161/01.cir.91.7.1952.'}]}, 'descriptionModule': {'briefSummary': 'To investigate hemostatic variables in relation to cardiovascular risk in the Framingham Offspring Study cohort.', 'detailedDescription': 'BACKGROUND:\n\nElevation of platelet reactivity plasminogen activator inhibitor, fibrinogen, von Willebrand\'s factor, and factor VII have been reported to increase myocardial infarction risk. Myocardial infarction and sudden cardiac death are more frequent in the morning when platelet activity is increased and fibrinolysis is decreased. Reduction of recurrent myocardial infarction by aspirin and coumadin suggests causal roles for platelet activity and coagulation. Increases in viscosity and decreases in anti-thrombin III and Protein C have been linked with increased thrombosis. Despite these findings, a coherent picture of these disparate hemostatic indices as cardiac risk factors has yet to emerge.\n\nDESIGN NARRATIVE:\n\nPlatelet reactivty, plasminogen activatator inhibitor, fibrinogen, von Willebrand\'s factor, factor VII, and other hemostatic risk factors were measured in all 4,000 subjects of the Framingham Offspring Study. The data were combined with the regularly collected Framingham data to: determine the relationships between hemostatic factors and carotid atherosclerosis as assessed by ultrasound; determine the relationship between hemostatic factors and the traditional cardiac risk factors; and determine if hemostatic risk factors independently predict myocardial infarction and cardiac death.\n\nThe study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'No eligibility criteria'}, 'identificationModule': {'nctId': 'NCT00005356', 'briefTitle': 'Novel Hemostatic Cardiac Risk Factors in Framingham', 'organization': {'class': 'NIH', 'fullName': 'National Heart, Lung, and Blood Institute (NHLBI)'}, 'orgStudyIdInfo': {'id': '4242'}, 'secondaryIdInfos': [{'id': 'R01HL048157', 'link': 'https://reporter.nih.gov/quickSearch/R01HL048157', 'type': 'NIH'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Geoffrey Tofler', 'affiliation': 'Beth Israel Deaconess Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}}}}