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

January 9, 2009 updated by: Preventive Medicine Research Institute

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

131

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sausalito, California, United States, 94965
        • Preventive Medicine Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Biomarkers of Cardiovascular Disease
Time Frame: Baseline Assessment, 3 month Follow-up Assessment, 12 month Follow-up Assessment
Baseline Assessment, 3 month Follow-up Assessment, 12 month Follow-up Assessment

Secondary Outcome Measures

Outcome Measure
Time Frame
Dietary Intake
Time Frame: Baseline Assessment, 3 month Follow-up Assessment, 12 month Follow-up Assessment
Baseline Assessment, 3 month Follow-up Assessment, 12 month Follow-up Assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Anticipated)

May 1, 2009

Study Completion (Anticipated)

May 1, 2009

Study Registration Dates

First Submitted

January 8, 2009

First Submitted That Met QC Criteria

January 9, 2009

First Posted (Estimate)

January 12, 2009

Study Record Updates

Last Update Posted (Estimate)

January 12, 2009

Last Update Submitted That Met QC Criteria

January 9, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPMC-26.096SLH
  • W81XHW-06-1-0565

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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