A Prospective Evaluation of Health Services Outcomes and Emerging Cardiovascular Disease Biomarkers
NCT ID: NCT00820313
Last Updated: 2009-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
131 participants
INTERVENTIONAL
2006-10-31
2009-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Global Profiling of Gene and Protein Expression Associated With Coronary Heart Disease Reversal
NCT01805492
Enhancing Support for Women at Risk for Heart Disease
NCT00142701
Denver Health Cardiovascular Disease (CVD) Prevention Program
NCT00829491
Self-screening of Cardiovascular Risk
NCT02373319
Strategies to Maintain Cardiac Risk Control After Discharge From Cardiovascular Risk Reduction Clinic
NCT00358033
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lifestyle Intervention
Comprehensive lifestyle intervention for reversal of heart disease
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Preventive Medicine Research Institute
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Preventive Medicine Research Institute
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Edward Kersh, MD, FACC
Role: PRINCIPAL_INVESTIGATOR
St. Luke's Hospital/California Pacific Cardiovascular Medical Group, Inc
Dean Ornish, MD
Role: PRINCIPAL_INVESTIGATOR
Preventive Medicine Research Institute
Gerdi Weidner, PhD
Role: PRINCIPAL_INVESTIGATOR
Preventive Medicine Research Institute
Nita Chainani-Wu, DMD, MS, PhD
Role: STUDY_DIRECTOR
Preventive Medicine Research Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Preventive Medicine Research Institute
Sausalito, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Preventive Medicine Research Institute website homepage
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
W81XHW-06-1-0565
Identifier Type: -
Identifier Source: secondary_id
CPMC-26.096SLH
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.