Global Profiling of Gene and Protein Expression Associated With Coronary Heart Disease Reversal
NCT ID: NCT01805492
Last Updated: 2013-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
422 participants
INTERVENTIONAL
2000-01-31
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention
Dr. Dean Ornish Program for Reversing Heart Disease
Dr. Dean Ornish Program for Reversing Heart Disease
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.
Control
Non-intervention controls retrospectively matched to intervention participants
No interventions assigned to this group
Interventions
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Dr. Dean Ornish Program for Reversing Heart Disease
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.
Eligibility Criteria
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Inclusion Criteria
* stable angina
* angioplasty
* evidence of \>50% luminal narrowing on coronary angiogram
* acute myocardial infarction
* bypass surgery
* stent placement OR
* two or more CAD risk factors
* systolic pressure \>140 mm Hg or diastolic pressure \>90 mm Hg)
* high total cholesterol (\>200 mg/dL)
* physician diagnosed diabetes
* body mass index (BMI) \>30
* family history of heart disease in parents or siblings
* 21 years of age or older
* mentally competent to provide informed consent
Exclusion Criteria
* systemic/chronic disease requiring chemotherapy or long term treatment
21 Years
ALL
No
Sponsors
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Windber Research Institute
OTHER
Responsible Party
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Darrell L Ellsworth
Senior Director, Integrative Cardiac Health Program
Principal Investigators
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Darrell L Ellsworth, PhD
Role: PRINCIPAL_INVESTIGATOR
Windber Research Institute
Locations
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Windber Medical Center
Windber, Pennsylvania, United States
Countries
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References
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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.
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.
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.
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.
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.
Related Links
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Windber Research Institute home page
Other Identifiers
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MDA W81XWH-05-2-0075
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
WRI-03-03
Identifier Type: -
Identifier Source: org_study_id
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