Global Profiling of Gene and Protein Expression Associated With Coronary Heart Disease Reversal
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Diseases
- Sponsor
- Windber Research Institute
- Enrollment
- 422
- Locations
- 1
- Primary Endpoint
- Change in body mass index
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Darrell L Ellsworth
Senior Director, Integrative Cardiac Health Program
Windber Research Institute
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)
Exclusion Criteria
- •known history of autoimmune disease
- •systemic/chronic disease requiring chemotherapy or long term treatment
Outcomes
Primary Outcomes
Change in body mass index
Time Frame: Baseline, 12 weeks, 52 weeks
Change in BMI from baseline to 12 weeks and from baseline to 52 weeks
Secondary Outcomes
- 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)