A Prospective Evaluation of Health Services Outcomes and Emerging Cardiovascular Disease Biomarkers
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|ClinicalTrials.gov Identifier: NCT00820313|
Recruitment Status : Unknown
Verified January 2009 by Preventive Medicine Research Institute.
Recruitment status was: Active, not recruiting
First Posted : January 12, 2009
Last Update Posted : January 12, 2009
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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.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Heart Disease Biomarkers of Cardiovascular Disease||Behavioral: Dr. Dean Ornish Program for Reversing Heart Disease||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||131 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Coronary Events, Risk Factors, and Quality of Life in Men and Women Enrolled in Intensive Lifestyle Interventions - A Prospective Evaluation of Health Services Outcomes and Emerging Cardiovascular Disease Biomarkers|
|Study Start Date :||October 2006|
|Estimated Primary Completion Date :||May 2009|
|Estimated Study Completion Date :||May 2009|
Comprehensive lifestyle intervention for reversal of heart disease
Behavioral: Dr. Dean Ornish Program for Reversing Heart Disease
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.
- Biomarkers of Cardiovascular Disease [ Time Frame: Baseline Assessment, 3 month Follow-up Assessment, 12 month Follow-up Assessment ]
- Dietary Intake [ Time Frame: Baseline Assessment, 3 month Follow-up Assessment, 12 month Follow-up Assessment ]
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|Ages Eligible for Study:||21 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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 included:
- ischemic left main CHD, with an obstruction greater than 50%
- significant (>70%) proximal left anterior descending artery disease and proximal left circumflex artery disease and an ejection fraction less than 50%, *unstable angina
- hypotensive response to exercise (> 20mm Hg drop in systolic BP)
- history of exercise induced ventricular tachycardia or 3rd degree heart block without evidence of current stability
- CABG surgery within 4 weeks, unless approved by medical director
- MI within one month, unless approved by medical director\
- HF, with functional limitation and unresponsive to medications
- current tobacco user not concurrently enrolled in a smoking cessation program with 2-month history of smoking cessation
- uncontrolled malignant ventricular arrhythmia despite medications and/or implantable cardiac defibrillator (ICD), unless approved by medical director, resides beyond a one-hour commute to the Program site, unless approved by Team, *history of substance abuse disorder (inc. ETOH) without documentation of a minimum one year of abstinence
- history of a significant psychiatric disorder without documentation of minimum one-year stability
- impaired cognitive function, such as dementia or delirium
- English language literacy unless Program site can accommodate
- uncooperative spouse or life partner, defined as obstructive in attitude or behavior
- the patient is deemed to be potentially disruptive to group setting by the screening team.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00820313
|United States, California|
|Preventive Medicine Research Institute|
|Sausalito, California, United States, 94965|
|Principal Investigator:||Edward Kersh, MD, FACC||St. Luke's Hospital/California Pacific Cardiovascular Medical Group, Inc|
|Principal Investigator:||Dean Ornish, MD||Preventive Medicine Research Institute|
|Principal Investigator:||Gerdi Weidner, PhD||Preventive Medicine Research Institute|
|Study Director:||Nita Chainani-Wu, DMD, MS, PhD||Preventive Medicine Research Institute|
|Responsible Party:||Dean Ornish, MD, Preventive Medicine Research Institute|
|Other Study ID Numbers:||
|First Posted:||January 12, 2009 Key Record Dates|
|Last Update Posted:||January 12, 2009|
|Last Verified:||January 2009|
Coronary Heart Disease
Biomarkers of Cardiovascular Disease
Health Related Quality of Life
Coronary Artery Disease
Arterial Occlusive Diseases