Global Profiling of Gene and Protein Expression Associated With Coronary Heart Disease Reversal

Study 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.

Official Title
-----------------
Global Profiling of Gene and Protein Expression Associated With Coronary Heart Disease Reversal

Conditions
-----------------
Heart Diseases, Cardiovascular Diseases

Intervention / Treatment
-----------------
* Behavioral: Dr. Dean Ornish Program for Reversing Heart Disease


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Dr. Dean Ornish Program for Reversing Heart Disease | Behavioral: Dr. Dean Ornish Program for Reversing Heart Disease<br>* 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.<br>|
| No Intervention: Control<br>Non-intervention controls retrospectively matched to intervention participants | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood pressure | Change in BP from baseline to 12 weeks and from baseline to 52 weeks | Baseline, 12 weeks, 52 weeks | 
| 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 | 
| Change in exercise capacity | Change in exercise capacity from baseline to 12 weeks and from baseline to 52 weeks | Baseline, 12 weeks, 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart diseases, Cardiovascular diseases, Lifestyle modification, Diet, Exercise