Cardiovascular Diseases Clinical Trial
Official title:
Global Profiling of Gene and Protein Expression Associated With Coronary Heart Disease Reversal
Verified date | March 2013 |
Source | Windber Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 422 |
Est. completion date | February 2009 |
Est. primary completion date | February 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: - 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 - 21 years of age or older - mentally competent to provide informed consent Exclusion Criteria: - known history of autoimmune disease - systemic/chronic disease requiring chemotherapy or long term treatment |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Windber Medical Center | Windber | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Windber Research Institute |
United States,
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 — View 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 — View 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.0000300264.0776 — View 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.num — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in body mass index | Change in BMI from baseline to 12 weeks and from baseline to 52 weeks | Baseline, 12 weeks, 52 weeks | No |
Secondary | Change in blood pressure | Change in BP from baseline to 12 weeks and from baseline to 52 weeks | Baseline, 12 weeks, 52 weeks | No |
Secondary | Change in lipids | Change in HDL-, LDL-, total cholesterol, and triglycerides from baseline to 12 weeks and from baseline to 52 weeks | Baseline, 12 weeks, 52 weeks | No |
Secondary | Change in exercise capacity | Change in exercise capacity from baseline to 12 weeks and from baseline to 52 weeks | Baseline, 12 weeks, 52 weeks | No |
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