Global Profiling of Gene and Protein Expression Associated With Coronary Heart Disease Reversal
2 other identifiers
interventional
422
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2000
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 21, 2013
CompletedFirst Posted
Study publicly available on registry
March 6, 2013
CompletedMarch 6, 2013
March 1, 2013
9.1 years
February 21, 2013
March 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in body mass index
Change in BMI from baseline to 12 weeks and from baseline to 52 weeks
Baseline, 12 weeks, 52 weeks
Secondary Outcomes (3)
Change in blood pressure
Baseline, 12 weeks, 52 weeks
Change in lipids
Baseline, 12 weeks, 52 weeks
Change in exercise capacity
Baseline, 12 weeks, 52 weeks
Study Arms (2)
Intervention
EXPERIMENTALDr. Dean Ornish Program for Reversing Heart Disease
Control
NO INTERVENTIONNon-intervention controls retrospectively matched to intervention participants
Interventions
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
You may qualify if:
- diagnosis of coronary artery disease (CAD)
- 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
- years of age or older
- mentally competent to provide informed consent
You may not qualify if:
- known history of autoimmune disease
- systemic/chronic disease requiring chemotherapy or long term treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Windber Medical Center
Windber, Pennsylvania, 15963, United States
Related Publications (5)
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: 15539963RESULTVizza 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: 18197071RESULTDecewicz 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: 19563671RESULTVoeghtly 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: 22633795RESULTEllsworth 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.
PMID: 24563419DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Darrell L Ellsworth, PhD
Windber Research Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Director, Integrative Cardiac Health Program
Study Record Dates
First Submitted
February 21, 2013
First Posted
March 6, 2013
Study Start
January 1, 2000
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
March 6, 2013
Record last verified: 2013-03