Nctid:
NCT00000594
Payload:
{"FullStudy"=>{"Rank"=>475015, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 08, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000002318", "ConditionMeshTerm"=>"Cardiovascular Diseases"}, {"ConditionMeshId"=>"D000009203", "ConditionMeshTerm"=>"Myocardial Infarction"}, {"ConditionMeshId"=>"D000006331", "ConditionMeshTerm"=>"Heart Diseases"}, {"ConditionMeshId"=>"D000003327", "ConditionMeshTerm"=>"Coronary Disease"}, {"ConditionMeshId"=>"D000017202", "ConditionMeshTerm"=>"Myocardial Ischemia"}, {"ConditionMeshId"=>"D000006938", "ConditionMeshTerm"=>"Hyperlipoproteinemia Type II"}, {"ConditionMeshId"=>"D000006937", "ConditionMeshTerm"=>"Hypercholesterolemia"}, {"ConditionMeshId"=>"D000007238", "ConditionMeshTerm"=>"Infarction"}, {"ConditionMeshId"=>"D000007511", "ConditionMeshTerm"=>"Ischemia"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000010335", "ConditionAncestorTerm"=>"Pathologic Processes"}, {"ConditionAncestorId"=>"D000009336", "ConditionAncestorTerm"=>"Necrosis"}, {"ConditionAncestorId"=>"D000014652", "ConditionAncestorTerm"=>"Vascular Diseases"}, {"ConditionAncestorId"=>"D000006949", "ConditionAncestorTerm"=>"Hyperlipidemias"}, {"ConditionAncestorId"=>"D000050171", "ConditionAncestorTerm"=>"Dyslipidemias"}, {"ConditionAncestorId"=>"D000052439", "ConditionAncestorTerm"=>"Lipid Metabolism Disorders"}, {"ConditionAncestorId"=>"D000008659", "ConditionAncestorTerm"=>"Metabolic Diseases"}, {"ConditionAncestorId"=>"D000008052", "ConditionAncestorTerm"=>"Lipid Metabolism, Inborn Errors"}, {"ConditionAncestorId"=>"D000008661", "ConditionAncestorTerm"=>"Metabolism, Inborn Errors"}, {"ConditionAncestorId"=>"D000030342", "ConditionAncestorTerm"=>"Genetic Diseases, Inborn"}, {"ConditionAncestorId"=>"D000006951", "ConditionAncestorTerm"=>"Hyperlipoproteinemias"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M6236", "ConditionBrowseLeafName"=>"Coronary Artery Disease", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11845", "ConditionBrowseLeafName"=>"Myocardial Infarction", "ConditionBrowseLeafAsFound"=>"Myocardial Infarction", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M9972", "ConditionBrowseLeafName"=>"Infarction", "ConditionBrowseLeafAsFound"=>"Infarction", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M10233", "ConditionBrowseLeafName"=>"Ischemia", "ConditionBrowseLeafAsFound"=>"Ischemia", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M19196", "ConditionBrowseLeafName"=>"Myocardial Ischemia", "ConditionBrowseLeafAsFound"=>"Myocardial Ischemia", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M6239", "ConditionBrowseLeafName"=>"Coronary Disease", "ConditionBrowseLeafAsFound"=>"Coronary Disease", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M9109", "ConditionBrowseLeafName"=>"Heart Diseases", "ConditionBrowseLeafAsFound"=>"Heart Disease", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M9678", "ConditionBrowseLeafName"=>"Hypercholesterolemia", "ConditionBrowseLeafAsFound"=>"Hypercholesterolemia", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M9692", "ConditionBrowseLeafName"=>"Hyperlipoproteinemias", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9690", "ConditionBrowseLeafName"=>"Hyperlipidemias", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M9679", "ConditionBrowseLeafName"=>"Hyperlipoproteinemia Type II", "ConditionBrowseLeafAsFound"=>"Hypercholesterolemia, Familial", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M11974", "ConditionBrowseLeafName"=>"Necrosis", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17090", "ConditionBrowseLeafName"=>"Vascular Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M25871", "ConditionBrowseLeafName"=>"Dyslipidemias", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11329", "ConditionBrowseLeafName"=>"Metabolic Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M26719", "ConditionBrowseLeafName"=>"Lipid Metabolism Disorders", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10744", "ConditionBrowseLeafName"=>"Lipid Metabolism, Inborn Errors", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11331", "ConditionBrowseLeafName"=>"Metabolism, Inborn Errors", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M23376", "ConditionBrowseLeafName"=>"Genetic Diseases, Inborn", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Heart and Blood Diseases", "ConditionBrowseBranchAbbrev"=>"BC14"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"Nutritional and Metabolic Diseases", "ConditionBrowseBranchAbbrev"=>"BC18"}, {"ConditionBrowseBranchName"=>"Diseases and Abnormalities at or Before Birth", "ConditionBrowseBranchAbbrev"=>"BC16"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000002792", "InterventionMeshTerm"=>"Cholestyramine Resin"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000000924", "InterventionAncestorTerm"=>"Anticholesteremic Agents"}, {"InterventionAncestorId"=>"D000000960", "InterventionAncestorTerm"=>"Hypolipidemic Agents"}, {"InterventionAncestorId"=>"D000000963", "InterventionAncestorTerm"=>"Antimetabolites"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}, {"InterventionAncestorId"=>"D000057847", "InterventionAncestorTerm"=>"Lipid Regulating Agents"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M5722", "InterventionBrowseLeafName"=>"Cholestyramine Resin", "InterventionBrowseLeafAsFound"=>"Compact", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M3933", "InterventionBrowseLeafName"=>"Anticholesteremic Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3968", "InterventionBrowseLeafName"=>"Hypolipidemic Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M3971", "InterventionBrowseLeafName"=>"Antimetabolites", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M28573", "InterventionBrowseLeafName"=>"Lipid Regulating Agents", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"Lipid Regulating Agents", "InterventionBrowseBranchAbbrev"=>"Lipd"}, {"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 3"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"Double"}, "DesignPrimaryPurpose"=>"Prevention"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"November 1971"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"April 2012", "CompletionDateStruct"=>{"CompletionDate"=>"November 1976", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"April 26, 2012", "StudyFirstSubmitDate"=>"October 27, 1999", "StudyFirstSubmitQCDate"=>"October 27, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"April 27, 2012", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"October 28, 1999", "StudyFirstPostDateType"=>"Estimate"}}, "ConditionsModule"=>{"ConditionList"=>{"Condition"=>["Cardiovascular Diseases", "Coronary Disease", "Heart Diseases", "Hypercholesterolemia, Familial", "Myocardial Infarction", "Myocardial Ischemia"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"168493", "ReferenceType"=>"background", "ReferenceCitation"=>"Borer JS, Brensike JF, Redwood DR, Itscoitz SB, Passamani ER, Stone NJ, Richardson JM, Levy RI, Epstein SE. Limitations of the electrocardiographic response to exercise in predicting coronary-artery disease. N Engl J Med. 1975 Aug 21;293(8):367-71. doi: 10.1056/NEJM197508212930801."}, {"ReferencePMID"=>"190398", "ReferenceType"=>"background", "ReferenceCitation"=>"Belmaker RH, Pollin W, Jenkins CD, Brensike J. Coronary prone behavior pattern in a sample of type II hypercholesteremic patients. J Psychosom Res. 1976;20(6):591-4. doi: 10.1016/0022-3999(76)90061-1. No abstract available."}, {"ReferencePMID"=>"582024", "ReferenceType"=>"background", "ReferenceCitation"=>"Aldrich RF, Brensike JF, Battaglini JW, Richardson JM, Loh IK, Stone NJ, Passamani ER, Ackerstein H, Seningen R, Borer JS, Levy RI, Epstein SE. Coronary calcifications in the detection of coronary artery disease and comparison with electrocardiographic exercise testing. Results from the National Heart, Lung, and Blood Institute's type II coronary intervention study. Circulation. 1979 Jun;59(6):1113-24. doi: 10.1161/01.cir.59.6.1113. No abstract available."}, {"ReferencePMID"=>"6749427", "ReferenceType"=>"background", "ReferenceCitation"=>"Brensike JF, Kelsey SF, Passamani ER, Fisher MR, Richardson JM, Loh IK, Stone NJ, Aldrich RF, Battaglini JW, Moriarty DJ, Myrianthopoulos MB, Detre KM, Epstein SE, Levy RI. National Heart, Lung, and Blood Institute type II Coronary Intervention Study: design, methods, and baseline characteristics. Control Clin Trials. 1982 Jun;3(2):91-111. doi: 10.1016/0197-2456(82)90038-1."}, {"ReferencePMID"=>"6360414", "ReferenceType"=>"background", "ReferenceCitation"=>"Brensike JF, Levy RI, Kelsey SF, Passamani ER, Richardson JM, Loh IK, Stone NJ, Aldrich RF, Battaglini JW, Moriarty DJ, et al. Effects of therapy with cholestyramine on progression of coronary arteriosclerosis: results of the NHLBI Type II Coronary Intervention Study. Circulation. 1984 Feb;69(2):313-24. doi: 10.1161/01.cir.69.2.313."}, {"ReferencePMID"=>"6360415", "ReferenceType"=>"background", "ReferenceCitation"=>"Levy RI, Brensike JF, Epstein SE, Kelsey SF, Passamani ER, Richardson JM, Loh IK, Stone NJ, Aldrich RF, Battaglini JW, et al. The influence of changes in lipid values induced by cholestyramine and diet on progression of coronary artery disease: results of NHLBI Type II Coronary Intervention Study. Circulation. 1984 Feb;69(2):325-37. doi: 10.1161/01.cir.69.2.325."}, {"ReferencePMID"=>"2912435", "ReferenceType"=>"background", "ReferenceCitation"=>"Brown BG, Lin JT, Kelsey S, Passamani ER, Levy RI, Dodge HT, Detre KM. Progression of coronary atherosclerosis in patients with probable familial hypercholesterolemia. Quantitative arteriographic assessment of patients in NHLBI type II study. Arteriosclerosis. 1989 Jan-Feb;9(1 Suppl):I81-90."}]}}, "DescriptionModule"=>{"BriefSummary"=>"To determine whether lowering of cholesterol with cholestyramine in a population with Type II hyperlipidemia led to a decreased rate of progression (a regression of coronary artery disease) as demonstrated by death, myocardial infarction, or progression of disease on angiography.", "DetailedDescription"=>"BACKGROUND:\n\nThere is overwhelming evidence that increased cholesterol levels are associated with increased risk of cardiovascular disease. This study examined whether lowering of cholesterol through drug therapy in people who had coronary artery disease as determined by angiography led to regression of the disease, again as indicated by angiography and reduction in mortality or nonfatal myocardial infarction. The study should be contrasted with the Coronary Primary Prevention Trial (CPPT), which determined whether lowering cholesterol through a combination of drug and diet therapy resulted in decreased cardiovascular mortality. It should be noted that patients in the CPPT did not have known preexisting coronary heart disease.\n\nDESIGN NARRATIVE:\n\nA randomized, double-blind trial, with single experimental and control groups. The experimental group received drug therapy (cholestyramine); the control group received placebo. Both groups received diet therapy. The endpoints were a significant difference in the progression of coronary disease as shown by angiography or a significant difference in new myocardial infarction or death. Patients were followed under therapy for at least 5 years."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"55 years", "MinimumAge"=>"21 years", "StdAgeList"=>{"StdAge"=>["Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Men and women with angiographically demonstrated coronary artery disease."}, "IdentificationModule"=>{"NCTId"=>"NCT00000594", "BriefTitle"=>"NHLBI Type II Coronary Intervention Study", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Heart, Lung, and Blood Institute (NHLBI)"}, "OrgStudyIdInfo"=>{"OrgStudyId"=>"400"}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"cholestyramine", "InterventionType"=>"Drug"}]}}, "ContactsLocationsModule"=>{"OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"John Brensike", "OverallOfficialAffiliation"=>"Cardiology Branch, NHLBI"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Heart, Lung, and Blood Institute (NHLBI)", "LeadSponsorClass"=>"NIH"}}}}}}
