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

NCT00820313 | Unknown

• 2 other identifiers: CPMC-26.096SLHW81XHW-06-1-0565
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease; Biomarkers of Cardiovascular Disease

Keywords

Coronary Heart Disease; Biomarkers of Cardiovascular Disease; Health Related Quality of Life; Diabetes; Diet

Outcome Measures

Primary Outcomes (1)

• Biomarkers of Cardiovascular Disease

  Baseline Assessment, 3 month Follow-up Assessment, 12 month Follow-up Assessment

Secondary Outcomes (1)

• Dietary Intake

  Baseline Assessment, 3 month Follow-up Assessment, 12 month Follow-up Assessment

Study Arms (1)

Lifestyle Intervention

OTHER

Comprehensive lifestyle intervention for reversal of heart disease

Behavioral: Dr. Dean Ornish Program for Reversing Heart Disease

Interventions

Dr. Dean Ornish Program for Reversing Heart Disease BEHAVIORAL

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.

Lifestyle Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Preventive Medicine Research Institute: lead

Study Sites (1)

Preventive Medicine Research Institute

Sausalito, California, 94965, United States

Location

Related Publications (8)

• 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.

  PMID: 18923113 BACKGROUND

• 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.

  PMID: 18823185 BACKGROUND

• 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.

  PMID: 18825581 BACKGROUND

• 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.

  PMID: 18359307 BACKGROUND

• 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.

  PMID: 17572148 BACKGROUND

• 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.

  PMID: 17291171 BACKGROUND

• 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.

  PMID: 16094059 BACKGROUND

• 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.

  PMID: 9863851 BACKGROUND

Related Links

• Preventive Medicine Research Institute website homepage

MeSH Terms

Conditions

Coronary Disease; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Nita Chainani-Wu, DMD, MS, PhD

  Preventive Medicine Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 8, 2009
• First Posted: January 12, 2009
• Study Start: October 1, 2006
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: January 12, 2009

Record last verified: 2009-01

Locations

US (1)