Nctid:
NCT00000471
Payload:
{"FullStudy"=>{"Rank"=>498856, "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"}, {"ConditionMeshId"=>"D000006937", "ConditionMeshTerm"=>"Hypercholesterolemia"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"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"=>"D000001157", "ConditionAncestorTerm"=>"Arterial Occlusive Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M6546", "ConditionBrowseLeafName"=>"Coronary Artery Disease", "ConditionBrowseLeafAsFound"=>"Coronary Arteriosclerosis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M10543", "ConditionBrowseLeafName"=>"Ischemia", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10024", "ConditionBrowseLeafName"=>"Hypertension", "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"=>"M9988", "ConditionBrowseLeafName"=>"Hypercholesterolemia", "ConditionBrowseLeafAsFound"=>"Hypercholesterolemia", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M4469", "ConditionBrowseLeafName"=>"Arteriosclerosis", "ConditionBrowseLeafAsFound"=>"Arteriosclerosis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M17400", "ConditionBrowseLeafName"=>"Vascular Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10000", "ConditionBrowseLeafName"=>"Hyperlipidemias", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10002", "ConditionBrowseLeafName"=>"Hyperlipoproteinemias", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M26181", "ConditionBrowseLeafName"=>"Dyslipidemias", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11639", "ConditionBrowseLeafName"=>"Metabolic Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M27029", "ConditionBrowseLeafName"=>"Lipid Metabolism Disorders", "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"}, {"ConditionBrowseBranchName"=>"Nutritional and Metabolic Diseases", "ConditionBrowseBranchAbbrev"=>"BC18"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 2"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignPrimaryPurpose"=>"Prevention"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"April 1989"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"January 2000", "CompletionDateStruct"=>{"CompletionDate"=>"March 1993", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"December 12, 2013", "StudyFirstSubmitDate"=>"October 27, 1999", "StudyFirstSubmitQCDate"=>"October 27, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"December 13, 2013", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"October 28, 1999", "StudyFirstPostDateType"=>"Estimate"}}, "ConditionsModule"=>{"ConditionList"=>{"Condition"=>["Cardiovascular Diseases", "Coronary Arteriosclerosis", "Coronary Disease", "Heart Diseases", "Hypercholesterolemia", "Hypertension", "Myocardial Ischemia"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"1973470", "ReferenceType"=>"background", "ReferenceCitation"=>"Ornish D, Brown SE, Scherwitz LW, Billings JH, Armstrong WT, Ports TA, McLanahan SM, Kirkeeide RL, Brand RJ, Gould KL. Can lifestyle changes reverse coronary heart disease? The Lifestyle Heart Trial. Lancet. 1990 Jul 21;336(8708):129-33. doi: 10.1016/0140-6736(90)91656-u."}, {"ReferencePMID"=>"1550011", "ReferenceType"=>"background", "ReferenceCitation"=>"Gould KL, Ornish D, Kirkeeide R, Brown S, Stuart Y, Buchi M, Billings J, Armstrong W, Ports T, Scherwitz L. Improved stenosis geometry by quantitative coronary arteriography after vigorous risk factor modification. Am J Cardiol. 1992 Apr 1;69(9):845-53. doi: 10.1016/0002-9149(92)90781-s."}, {"ReferencePMID"=>"7674504", "ReferenceType"=>"background", "ReferenceCitation"=>"Gould KL, Ornish D, Scherwitz L, Brown S, Edens RP, Hess MJ, Mullani N, Bolomey L, Dobbs F, Armstrong WT, et al. Changes in myocardial perfusion abnormalities by positron emission tomography after long-term, intense risk factor modification. JAMA. 1995 Sep 20;274(11):894-901. doi: 10.1001/jama.1995.03530110056036."}]}}, "DescriptionModule"=>{"BriefSummary"=>"To assess long-term effects of a strict lifestyle change program on lipids, blood pressure, myocardial perfusion, and coronary atherosclerosis.", "DetailedDescription"=>"BACKGROUND:\n\nThe trial was the first randomized, controlled trial to determine whether patients outside a hospital could be motivated to make and sustain comprehensive lifestyle changes and whether coronary disease regression could occur as a result of lifestyle changes alone.\n\nDESIGN NARRATIVE:\n\nPatients were randomly assigned to an experimental group or to a usual-care group. Experimental-group patients were prescribed a lifestyle program including a low-fat vegetarian diet, moderate aerobic exercise, stress management training, stopping smoking, and group support. No animal products were allowed in the vegetarian diet except egg white and one cup per day of non-fat milk or yogurt. The diet contained approximately 10 percent of calories as fat. Control-group patients were not asked to make lifestyle changes. Coronary angiography was performed at baseline and at one year to assess progression or regression of disease. Patients were recruited into the trial between January 1986 and November 1988. The trial was supported prior to April 1989 from various sources other than the National Heart, Lung, and Blood Institute. Follow-up continued for four years.\n\nThe study completion date listed in this record was obtained from the Query/View/Report (QVR) System."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"75 years", "MinimumAge"=>"35 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Men and women, ages 35 to 75, with angiographically documented one, two, or three vessel coronary disease; no myocardial infarction during the preceeding six weeks; and not receiving streptokinase, alteplase, or lipid-lowering drugs."}, "IdentificationModule"=>{"NCTId"=>"NCT00000471", "BriefTitle"=>"Lifestyle Heart Trial", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Heart, Lung, and Blood Institute (NHLBI)"}, "OrgStudyIdInfo"=>{"OrgStudyId"=>"60"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"R01HL042554", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/R01HL042554", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"diet, vegetarianism", "InterventionType"=>"Behavioral"}, {"InterventionName"=>"diet, fat-restricted", "InterventionType"=>"Behavioral"}, {"InterventionName"=>"exercise", "InterventionType"=>"Behavioral"}, {"InterventionName"=>"smoking cessation", "InterventionType"=>"Behavioral"}]}}, "ContactsLocationsModule"=>{"OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"K. Gould", "OverallOfficialAffiliation"=>"University of Texas"}, {"OverallOfficialName"=>"Dean Ornish", "OverallOfficialAffiliation"=>"University of California School of Medicine"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Heart, Lung, and Blood Institute (NHLBI)", "LeadSponsorClass"=>"NIH"}}}}}}
