Nctid:
NCT00000605
Payload:
{"FullStudy"=>{"Rank"=>498722, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"June 24, 2024"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000002318", "ConditionMeshTerm"=>"Cardiovascular Diseases"}, {"ConditionMeshId"=>"D000006331", "ConditionMeshTerm"=>"Heart Diseases"}, {"ConditionMeshId"=>"D000003327", "ConditionMeshTerm"=>"Coronary Disease"}, {"ConditionMeshId"=>"D000003324", "ConditionMeshTerm"=>"Coronary Artery Disease"}, {"ConditionMeshId"=>"D000017202", "ConditionMeshTerm"=>"Myocardial Ischemia"}, {"ConditionMeshId"=>"D000001161", "ConditionMeshTerm"=>"Arteriosclerosis"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000014652", "ConditionAncestorTerm"=>"Vascular Diseases"}, {"ConditionAncestorId"=>"D000001157", "ConditionAncestorTerm"=>"Arterial Occlusive Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M26188", "ConditionBrowseLeafName"=>"Atherosclerosis", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6546", "ConditionBrowseLeafName"=>"Coronary Artery Disease", "ConditionBrowseLeafAsFound"=>"Coronary Arteriosclerosis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M10543", "ConditionBrowseLeafName"=>"Ischemia", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9419", "ConditionBrowseLeafName"=>"Heart Diseases", "ConditionBrowseLeafAsFound"=>"Heart Disease", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M19506", "ConditionBrowseLeafName"=>"Myocardial Ischemia", "ConditionBrowseLeafAsFound"=>"Myocardial Ischemia", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M6549", "ConditionBrowseLeafName"=>"Coronary Disease", "ConditionBrowseLeafAsFound"=>"Coronary Disease", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M4469", "ConditionBrowseLeafName"=>"Arteriosclerosis", "ConditionBrowseLeafAsFound"=>"Arteriosclerosis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M17400", "ConditionBrowseLeafName"=>"Vascular Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M4465", "ConditionBrowseLeafName"=>"Arterial Occlusive Diseases", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Heart and Blood Diseases", "ConditionBrowseBranchAbbrev"=>"BC14"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000017258", "InterventionMeshTerm"=>"Medroxyprogesterone Acetate"}, {"InterventionMeshId"=>"D000008525", "InterventionMeshTerm"=>"Medroxyprogesterone"}, {"InterventionMeshId"=>"D000006728", "InterventionMeshTerm"=>"Hormones"}, {"InterventionMeshId"=>"D000004967", "InterventionMeshTerm"=>"Estrogens"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000006730", "InterventionAncestorTerm"=>"Hormones, Hormone Substitutes, and Hormone Antagonists"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}, {"InterventionAncestorId"=>"D000003278", "InterventionAncestorTerm"=>"Contraceptives, Oral, Hormonal"}, {"InterventionAncestorId"=>"D000003276", "InterventionAncestorTerm"=>"Contraceptives, Oral"}, {"InterventionAncestorId"=>"D000003271", "InterventionAncestorTerm"=>"Contraceptive Agents, Female"}, {"InterventionAncestorId"=>"D000003270", "InterventionAncestorTerm"=>"Contraceptive Agents"}, {"InterventionAncestorId"=>"D000012102", "InterventionAncestorTerm"=>"Reproductive Control Agents"}, {"InterventionAncestorId"=>"D000080066", "InterventionAncestorTerm"=>"Contraceptive Agents, Hormonal"}, {"InterventionAncestorId"=>"D000003280", "InterventionAncestorTerm"=>"Contraceptives, Oral, Synthetic"}, {"InterventionAncestorId"=>"D000003272", "InterventionAncestorTerm"=>"Contraceptive Agents, Male"}, {"InterventionAncestorId"=>"D000018931", "InterventionAncestorTerm"=>"Antineoplastic Agents, Hormonal"}, {"InterventionAncestorId"=>"D000000970", "InterventionAncestorTerm"=>"Antineoplastic Agents"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M9789", "InterventionBrowseLeafName"=>"Hormones", "InterventionBrowseLeafAsFound"=>"Delivery", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M19554", "InterventionBrowseLeafName"=>"Medroxyprogesterone Acetate", "InterventionBrowseLeafAsFound"=>"Glucose levels", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M11508", "InterventionBrowseLeafName"=>"Medroxyprogesterone", "InterventionBrowseLeafAsFound"=>"Glucose levels", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M8116", "InterventionBrowseLeafName"=>"Estrogens", "InterventionBrowseLeafAsFound"=>"PA", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M9788", "InterventionBrowseLeafName"=>"Hormone Antagonists", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M6494", "InterventionBrowseLeafName"=>"Contraceptive Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M6500", "InterventionBrowseLeafName"=>"Contraceptives, Oral", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M6502", "InterventionBrowseLeafName"=>"Contraceptives, Oral, Hormonal", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M6495", "InterventionBrowseLeafName"=>"Contraceptive Agents, Female", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M2116", "InterventionBrowseLeafName"=>"Contraceptive Agents, Hormonal", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M6496", "InterventionBrowseLeafName"=>"Contraceptive Agents, Male", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M20966", "InterventionBrowseLeafName"=>"Antineoplastic Agents, Hormonal", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Antineoplastic Agents", "InterventionBrowseBranchAbbrev"=>"ANeo"}, {"InterventionBrowseBranchName"=>"Reproductive Control Agents", "InterventionBrowseBranchAbbrev"=>"Repr"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 3"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"Double"}, "DesignPrimaryPurpose"=>"Prevention"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"August 1996"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"April 2005", "CompletionDateStruct"=>{"CompletionDate"=>"July 2002", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"February 17, 2016", "StudyFirstSubmitDate"=>"October 27, 1999", "StudyFirstSubmitQCDate"=>"October 27, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"February 18, 2016", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"October 28, 1999", "StudyFirstPostDateType"=>"Estimate"}}, "ConditionsModule"=>{"ConditionList"=>{"Condition"=>["Cardiovascular Diseases", "Coronary Arteriosclerosis", "Coronary Disease", "Heart Diseases", "Myocardial Ischemia", "Postmenopause"]}}, "DescriptionModule"=>{"BriefSummary"=>"To determine if postmenopausal hormone replacement therapy in women following coronary bypass surgery would reduce the occurrence of graft occlusion and delay the development of graft atherosclerosis.", "DetailedDescription"=>"BACKGROUND:\n\nCoronary atherosclerosis is a major cause of death in women in the United States. Although coronary artery bypass surgery decreases symptomatic and clinical evidence of ischemia, it does not alter the underlying process. Patients may present several years later with recurrent symptoms that may be a result of occlusion of saphenous vein grafts, development of atherosclerotic disease in vein grafts, or progression of underlying disease. Any intervention that can reduce the rate of progression of coronary atherosclerosis following bypass surgery would provide significant benefit for women following bypass surgery and possibly for other women with atherosclerotic disease. Observational studies suggest that postmenopausal estrogen replacement therapy is associated with a reduction in cardiac morbidity.\n\nDESIGN NARRATIVE:\n\nThe study was a randomized, double-blind, controlled trial. Subjects were randomized to conjugated estrogen with daily medroxyprogesterone or placebo within two weeks of bypass surgery. Graft occlusion and development of vein graft atherosclerosis were measured by comparing quantitative coronary angiographic and vascular ultrasonic assessment of disease severity and extent performed at six months and three and a half years after randomization. The primary outcome variables included the occurrence of graft occlusion at six months and the change in severity and extent of atherosclerosis in the saphenous vein grafts over three years. The trial determined the influence of hormone replacement therapy on the primary outcome variables.\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"=>{"Gender"=>"Female", "MaximumAge"=>"75 years", "MinimumAge"=>"45 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Postmenopausal women who had undergone coronary artery bypass graft."}, "IdentificationModule"=>{"NCTId"=>"NCT00000605", "BriefTitle"=>"Estrogen and Graft Atherosclerosis Research Trial (EAGER)", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Heart, Lung, and Blood Institute (NHLBI)"}, "OrgStudyIdInfo"=>{"OrgStudyId"=>"109"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"5U01HL050840", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/5U01HL050840", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"hormone replacement therapy", "InterventionType"=>"Drug"}, {"InterventionName"=>"estrogens", "InterventionType"=>"Drug"}, {"InterventionName"=>"medroxyprogesterone", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Pamela Ouyang", "OverallOfficialAffiliation"=>"Johns Hopkins University"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Heart, Lung, and Blood Institute (NHLBI)", "LeadSponsorClass"=>"NIH"}}}}}}
