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

Primary Purpose

Coronary Heart Disease, Biomarkers of Cardiovascular Disease

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dr. Dean Ornish Program for Reversing Heart Disease
Sponsored by
Preventive Medicine Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Heart Disease focused on measuring Coronary Heart Disease, Biomarkers of Cardiovascular Disease, Health Related Quality of Life, Diabetes, Diet

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 > 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.

Sites / Locations

  • Preventive Medicine Research Institute

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Lifestyle Intervention

Arm Description

Comprehensive lifestyle intervention for reversal of heart disease

Outcomes

Primary Outcome Measures

Biomarkers of Cardiovascular Disease

Secondary Outcome Measures

Dietary Intake

Full Information

First Posted
January 8, 2009
Last Updated
January 9, 2009
Sponsor
Preventive Medicine Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00820313
Brief Title
A Prospective Evaluation of Health Services Outcomes and Emerging Cardiovascular Disease Biomarkers
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 Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Unknown status
Study Start Date
October 2006 (undefined)
Primary Completion Date
May 2009 (Anticipated)
Study Completion Date
May 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Preventive Medicine Research Institute

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease, Biomarkers of Cardiovascular Disease
Keywords
Coronary Heart Disease, Biomarkers of Cardiovascular Disease, Health Related Quality of Life, Diabetes, Diet

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle Intervention
Arm Type
Other
Arm Description
Comprehensive lifestyle intervention for reversal of heart disease
Intervention Type
Behavioral
Intervention Name(s)
Dr. Dean Ornish Program for Reversing Heart Disease
Intervention Description
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.
Primary Outcome Measure Information:
Title
Biomarkers of Cardiovascular Disease
Time Frame
Baseline Assessment, 3 month Follow-up Assessment, 12 month Follow-up Assessment
Secondary Outcome Measure Information:
Title
Dietary Intake
Time Frame
Baseline Assessment, 3 month Follow-up Assessment, 12 month Follow-up Assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Kersh, MD, FACC
Organizational Affiliation
St. Luke's Hospital/California Pacific Cardiovascular Medical Group, Inc
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dean Ornish, MD
Organizational Affiliation
Preventive Medicine Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gerdi Weidner, PhD
Organizational Affiliation
Preventive Medicine Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nita Chainani-Wu, DMD, MS, PhD
Organizational Affiliation
Preventive Medicine Research Institute
Official's Role
Study Director
Facility Information:
Facility Name
Preventive Medicine Research Institute
City
Sausalito
State/Province
California
ZIP/Postal Code
94965
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18923113
Citation
Govil SR, Weidner G, Merritt-Worden T, Ornish D. Socioeconomic status and improvements in lifestyle, coronary risk factors, and quality of life: the Multisite Cardiac Lifestyle Intervention Program. Am J Public Health. 2009 Jul;99(7):1263-70. doi: 10.2105/AJPH.2007.132852. Epub 2008 Oct 15.
Results Reference
background
PubMed Identifier
18823185
Citation
Pischke CR, Scherwitz L, Weidner G, Ornish D. Long-term effects of lifestyle changes on well-being and cardiac variables among coronary heart disease patients. Health Psychol. 2008 Sep;27(5):584-92. doi: 10.1037/0278-6133.27.5.584.
Results Reference
background
PubMed Identifier
18825581
Citation
Schulz U, Pischke CR, Weidner G, Daubenmier J, Elliot-Eller M, Scherwitz L, Bullinger M, Ornish D. Social support group attendance is related to blood pressure, health behaviours, and quality of life in the Multicenter Lifestyle Demonstration Project. Psychol Health Med. 2008 Aug;13(4):423-37. doi: 10.1080/13548500701660442.
Results Reference
background
PubMed Identifier
18359307
Citation
Frattaroli J, Weidner G, Merritt-Worden TA, Frenda S, Ornish D. Angina pectoris and atherosclerotic risk factors in the multisite cardiac lifestyle intervention program. Am J Cardiol. 2008 Apr 1;101(7):911-8. doi: 10.1016/j.amjcard.2007.11.039. Epub 2008 Jan 28.
Results Reference
background
PubMed Identifier
17572148
Citation
Pischke CR, Weidner G, Elliott-Eller M, Ornish D. Lifestyle changes and clinical profile in coronary heart disease patients with an ejection fraction of <or=40% or >40% in the Multicenter Lifestyle Demonstration Project. Eur J Heart Fail. 2007 Sep;9(9):928-34. doi: 10.1016/j.ejheart.2007.05.009. Epub 2007 Jun 14.
Results Reference
background
PubMed Identifier
17291171
Citation
Daubenmier JJ, Weidner G, Sumner MD, Mendell N, Merritt-Worden T, Studley J, Ornish D. The contribution of changes in diet, exercise, and stress management to changes in coronary risk in women and men in the multisite cardiac lifestyle intervention program. Ann Behav Med. 2007 Feb;33(1):57-68. doi: 10.1207/s15324796abm3301_7.
Results Reference
background
PubMed Identifier
16094059
Citation
Ornish D, Weidner G, Fair WR, Marlin R, Pettengill EB, Raisin CJ, Dunn-Emke S, Crutchfield L, Jacobs FN, Barnard RJ, Aronson WJ, McCormac P, McKnight DJ, Fein JD, Dnistrian AM, Weinstein J, Ngo TH, Mendell NR, Carroll PR. Intensive lifestyle changes may affect the progression of prostate cancer. J Urol. 2005 Sep;174(3):1065-9; discussion 1069-70. doi: 10.1097/01.ju.0000169487.49018.73.
Results Reference
background
PubMed Identifier
9863851
Citation
Ornish D, Scherwitz LW, Billings JH, Brown SE, Gould KL, Merritt TA, Sparler S, Armstrong WT, Ports TA, Kirkeeide RL, Hogeboom C, Brand RJ. Intensive lifestyle changes for reversal of coronary heart disease. JAMA. 1998 Dec 16;280(23):2001-7. doi: 10.1001/jama.280.23.2001. Erratum In: JAMA 1999 Apr 21;281(15):1380.
Results Reference
background
Links:
URL
http://www.pmri.org/
Description
Preventive Medicine Research Institute website homepage

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

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