Clinical trial NCT01805492: Global Profiling of Gene and Protein Expression Associated With Coronary Heart Disease Reversal
Official title: Global Profiling of Gene and Protein Expression Associated With Coronary Heart Disease Reversal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Diseases
Cardiovascular Diseases
Keywords: Heart diseases
Cardiovascular diseases
Lifestyle modification
Diet
Exercise
Lead sponsor: Windber Research Institute
Sponsor class: OTHER
First posted: 2013-03-06
Enrollment: 422
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in body mass index
timeFrame: Baseline, 12 weeks, 52 weeks
Secondary outcomes:
measure: Change in blood pressure
timeFrame: Baseline, 12 weeks, 52 weeks
measure: Change in lipids
timeFrame: Baseline, 12 weeks, 52 weeks
measure: Change in exercise capacity
timeFrame: Baseline, 12 weeks, 52 weeks
Other outcomes:
Locations:
city: Windber
country: United States
facility: Windber Medical Center
state: Pennsylvania
Study officials:
affiliation: Windber Research Institute
name: Darrell L Ellsworth, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.