Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2025-12-25 @ 10:03 PM
Study NCT ID:
NCT01805492
Status:
COMPLETED
Last Update Posted:
2013-03-06
First Post:
2013-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Global Profiling of Gene and Protein Expression Associated With Coronary Heart Disease Reversal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 422}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-04', 'studyFirstSubmitDate': '2013-02-21', 'studyFirstSubmitQcDate': '2013-03-04', 'lastUpdatePostDateStruct': {'date': '2013-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in body mass index', 'timeFrame': 'Baseline, 12 weeks, 52 weeks', 'description': 'Change in BMI from baseline to 12 weeks and from baseline to 52 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in blood pressure', 'timeFrame': 'Baseline, 12 weeks, 52 weeks', 'description': 'Change in BP from baseline to 12 weeks and from baseline to 52 weeks'}, {'measure': 'Change in lipids', 'timeFrame': 'Baseline, 12 weeks, 52 weeks', 'description': 'Change in HDL-, LDL-, total cholesterol, and triglycerides from baseline to 12 weeks and from baseline to 52 weeks'}, {'measure': 'Change in exercise capacity', 'timeFrame': 'Baseline, 12 weeks, 52 weeks', 'description': 'Change in exercise capacity from baseline to 12 weeks and from baseline to 52 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heart diseases', 'Cardiovascular diseases', 'Lifestyle modification', 'Diet', 'Exercise'], 'conditions': ['Heart Diseases', 'Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '15539963', 'type': 'RESULT', 'citation': "Ellsworth DL, O'Dowd SC, Salami B, Hochberg A, Vernalis MN, Marshall D, Morris JA, Somiari RI. Intensive lifestyle modification: impact on cardiovascular disease risk factors in subjects with and without clinical cardiovascular disease. Prev Cardiol. 2004 Fall;7(4):168-75. doi: 10.1111/j.1520-037x.2004.3332.x."}, {'pmid': '18197071', 'type': 'RESULT', 'citation': 'Vizza J, Neatrour DM, Felton PM, Ellsworth DL. Improvement in psychosocial functioning during an intensive cardiovascular lifestyle modification program. J Cardiopulm Rehabil Prev. 2007 Nov-Dec;27(6):376-83; quiz 384-5. doi: 10.1097/01.HCR.0000300264.07764.84.'}, {'pmid': '19563671', 'type': 'RESULT', 'citation': 'Decewicz DJ, Neatrour DM, Burke A, Haberkorn MJ, Patney HL, Vernalis MN, Ellsworth DL. Effects of cardiovascular lifestyle change on lipoprotein subclass profiles defined by nuclear magnetic resonance spectroscopy. Lipids Health Dis. 2009 Jun 29;8:26. doi: 10.1186/1476-511X-8-26.'}, {'pmid': '22633795', 'type': 'RESULT', 'citation': 'Voeghtly LM, Neatrour DM, Decewicz DJ, Burke A, Haberkorn MJ, Lechak F, Patney HL, Vernalis MN, Ellsworth DL. Cardiometabolic risk reduction in an intensive cardiovascular health program. Nutr Metab Cardiovasc Dis. 2013 Jul;23(7):662-9. doi: 10.1016/j.numecd.2012.01.012. Epub 2012 May 26.'}, {'pmid': '24563419', 'type': 'DERIVED', 'citation': 'Ellsworth DL, Croft DT Jr, Weyandt J, Sturtz LA, Blackburn HL, Burke A, Haberkorn MJ, McDyer FA, Jellema GL, van Laar R, Mamula KA, Chen Y, Vernalis MN. Intensive cardiovascular risk reduction induces sustainable changes in expression of genes and pathways important to vascular function. Circ Cardiovasc Genet. 2014 Apr;7(2):151-60. doi: 10.1161/CIRCGENETICS.113.000121. Epub 2014 Feb 21.'}], 'seeAlsoLinks': [{'url': 'http://www.wriwindber.org/', 'label': 'Windber Research Institute home page'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to characterize changes in gene and protein expression in peripheral blood in patients with, or at risk for, heart disease during an intensive lifestyle modification program.', 'detailedDescription': 'This project will use an integrated approach that examines DNA variation and the functional products of genes at both the messenger RNA (mRNA) and protein levels to provide a global view of molecular changes associated with drastic lifestyle modifications designed to reverse coronary heart disease (CHD). DNA variants and/or changes in gene and protein expression associated with CHD reversal may provide important clues to understanding molecular mechanisms of subclinical CHD development and progression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of coronary artery disease (CAD)\n* stable angina\n* angioplasty\n* evidence of \\>50% luminal narrowing on coronary angiogram\n* acute myocardial infarction\n* bypass surgery\n* stent placement OR\n* two or more CAD risk factors\n* systolic pressure \\>140 mm Hg or diastolic pressure \\>90 mm Hg)\n* high total cholesterol (\\>200 mg/dL)\n* physician diagnosed diabetes\n* body mass index (BMI) \\>30\n* family history of heart disease in parents or siblings\n* 21 years of age or older\n* mentally competent to provide informed consent\n\nExclusion Criteria:\n\n* known history of autoimmune disease\n* systemic/chronic disease requiring chemotherapy or long term treatment'}, 'identificationModule': {'nctId': 'NCT01805492', 'briefTitle': 'Global Profiling of Gene and Protein Expression Associated With Coronary Heart Disease Reversal', 'organization': {'class': 'OTHER', 'fullName': 'Windber Research Institute'}, 'officialTitle': 'Global Profiling of Gene and Protein Expression Associated With Coronary Heart Disease Reversal', 'orgStudyIdInfo': {'id': 'WRI-03-03'}, 'secondaryIdInfos': [{'id': 'MDA W81XWH-05-2-0075', 'type': 'OTHER_GRANT', 'domain': 'Department of Defense'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Dr. Dean Ornish Program for Reversing Heart Disease', 'interventionNames': ['Behavioral: Dr. Dean Ornish Program for Reversing Heart Disease']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Non-intervention controls retrospectively matched to intervention participants'}], 'interventions': [{'name': 'Dr. Dean Ornish Program for Reversing Heart Disease', 'type': 'BEHAVIORAL', 'description': 'Prospective, nonrandomized clinical intervention to stabilize or reverse progression of heart disease through changes in lifestyle. Lifestyle intervention consisted of four components: 1) a very low fat vegetarian diet (\\<10% of calories from fat); 2) 180 minutes/week of moderate aerobic exercise; 3) one hour of stress management each day; and 4) weekly group support sessions.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15963', 'city': 'Windber', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Windber Medical Center', 'geoPoint': {'lat': 40.2398, 'lon': -78.83502}}], 'overallOfficials': [{'name': 'Darrell L Ellsworth, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Windber Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Windber Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Director, Integrative Cardiac Health Program', 'investigatorFullName': 'Darrell L Ellsworth', 'investigatorAffiliation': 'Windber Research Institute'}}}}