Clinical trial NCT00820313: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Heart Disease
Biomarkers of Cardiovascular Disease
Keywords: Coronary Heart Disease
Biomarkers of Cardiovascular Disease
Health Related Quality of Life
Diabetes
Diet
Lead sponsor: Preventive Medicine Research Institute
Sponsor class: OTHER
First posted: 2009-01-12
Enrollment: 131
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Biomarkers of Cardiovascular Disease
timeFrame: Baseline Assessment, 3 month Follow-up Assessment, 12 month Follow-up Assessment
Secondary outcomes:
measure: Dietary Intake
timeFrame: Baseline Assessment, 3 month Follow-up Assessment, 12 month Follow-up Assessment
Other outcomes:
Locations:
city: Sausalito
country: United States
facility: Preventive Medicine Research Institute
state: California
Study officials:
affiliation: St. Luke's Hospital/California Pacific Cardiovascular Medical Group, Inc
name: Edward Kersh, MD, FACC
role: PRINCIPAL_INVESTIGATOR
affiliation: Preventive Medicine Research Institute
name: Dean Ornish, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Preventive Medicine Research Institute
name: Gerdi Weidner, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Preventive Medicine Research Institute
name: Nita Chainani-Wu, DMD, MS, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.
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.