A Prospective Evaluation of Health Services Outcomes and Emerging Cardiovascular Disease Biomarkers

Sponsor

Preventive Medicine Research Institute (Other)

Overall Status

Unknown status

CT.gov ID

NCT00820313

Collaborator

(none)

131

Enrollment

Location

Arm

Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Heart Disease Biomarkers of Cardiovascular Disease	Behavioral: Dr. Dean Ornish Program for Reversing Heart Disease	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

131 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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 :

Oct 1, 2006

Anticipated Primary Completion Date :

May 1, 2009

Anticipated Study Completion Date :

May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: Lifestyle Intervention 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.

Arm

Intervention/Treatment

Other: Lifestyle Intervention

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.

Outcome Measures

Primary Outcome Measures

Biomarkers of Cardiovascular Disease [Baseline Assessment, 3 month Follow-up Assessment, 12 month Follow-up Assessment]

Secondary Outcome Measures

Dietary Intake [Baseline Assessment, 3 month Follow-up Assessment, 12 month Follow-up Assessment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 >

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:

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
non-ambulatory
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Preventive Medicine Research Institute	Sausalito	California	United States	94965

Sponsors and Collaborators

Preventive Medicine Research Institute

Investigators

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