Biomarkers of Cardiovascular Disease, Coronary Heart Disease
Conditions
Keywords
Coronary Heart Disease, Biomarkers of Cardiovascular Disease, Health Related Quality of Life, Diabetes, Diet
Brief summary
The primary aim of the proposed research is to examine the relationship of lifestyle changes to new dietary, biomedical, and cellular parameters among new enrollees entering the Dr. Dean Ornish Program for Reversing Heart Disease program at 5 selected sites. Specifically, the investigators will add assessments of emerging cardiac risk factors (e.g., high sensitivity C-reactive protein \[hsCRP\], fibrinogen, lipoprotein(a) \[Lp(a)\], small, dense LDL, apolipoprotein B \[apoB\], apolipoprotein A-I \[apo A1\], the apoB/apoA1 ratio, homocysteine \[Hcy\], B-type natriuretic peptide \[BNP\], oxidized LDL, fasting insulin and waist-to-hip ratio \[WHR\]), protective and pathogenic dietary markers (e.g., folate, carotenoids, trans fatty acids), and measures of social support and cognitive functioning to the already existing assessment variables in the Multisite Cardiac Lifestyle Intervention Program (MCLIP). Hypothesis 1: Participation in the lifestyle program will not only be associated with favorable changes in standard coronary risk factors and quality of life, but also with improvements in emerging cardiac risk factors \[hsCRP, Hcy, BNP, fibrinogen, Lp(a), small, dense LDL, apoB, apoA1, oxidized LDL, fasting insulin, and abdominal obesity\] and psychosocial well-being (i.e., social support, and cognitive functioning). Hypothesis 2: High intake of emerging protective dietary factors and low intake of emerging pathogenic dietary factors will be associated with improvements in both standard and emerging cardiac risk factors (e.g. Hcy, oxidized LDL). Hypothesis 3: Degree of adherence to the lifestyle change program will be associated with differential improvement in standard coronary risk factors, emerging risk factors, cellular aging, and psychosocial variables.
Interventions
Exercise: At least 3 hours of aerobic exercise per week, 30 minutes per session. Additionally, patients are asked to perform a minimum of 2 strength training sessions per week. Stress Management: Integrates stretching, relaxation, breathing techniques, meditation and guided imagery. Patients are asked to practice these techniques at least 1 hour per day. Diet: Approximately 10% daily calories from fat, 15% protein and 75% complex carbohydrates (low-fat, whole foods, primarily plant-based). Group Support: Weekly group support sessions provide social support to help patients adhere to and sustain the lifestyle-change program.
Sponsors
Preventive Medicine Research Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eligible patients included those who had a diagnosis of coronary heart disease (CHD) from their physician or health plan, a diagnosis of diabetes, or at least 3 additional cardiac risk factors. * A diagnosis of CHD included: * having diagnosed CHD based on non-invasive testing such as exercise testing, nuclear imaging, echocardiogram or other test that clearly demonstrates ischemia * cardiac catheterization demonstrating CHD * eligibility for bypass surgery/PTCA and seeking a clinical alternative * coronary bypass surgery * PTCA/stent * myocardial infarction. * Type I or Type II diabetics were eligible for the program. * For a participant to be included as a high-risk factor participant, the participant must have either a family history of premature CHD (1st-degree relative (male\<55; female \<65) with MI or sudden cardiac death) or be a male aged \> 45 or a female aged \> 55. * In addition, there must be at least two additional cardiovascular risk factors, including: * current cigarette smoking (within the past 5 years) * hypertension: BP \> 140/90 mm Hg or on antihypertensive medication, * low HDL-C: \<35 mg/dl or on medications for lipid therapy * elevated apolipoprotein(a): \>30 mg/dl or on medications for elevated lipids * high total cholesterol: \> 240 or on medications for elevated lipids * high LDL-C: \>160 or on medications for elevated lipids * high sensitivity C-Reactive Protein: \> 3 mg/dl and \< 10 mg/dl * obesity: BMI \> 30 * Insulin Resistant State (Metabolic Syndrome X
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biomarkers of Cardiovascular Disease | Baseline Assessment, 3 month Follow-up Assessment, 12 month Follow-up Assessment |
Secondary
| Measure | Time frame |
|---|---|
| Dietary Intake | Baseline Assessment, 3 month Follow-up Assessment, 12 month Follow-up Assessment |
Countries
United States
Outcome results
None listed